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20 February 2015

EMA/52196/2015 rev. 1
Procedure Management and Business Support

Products for which the marketing authorisations are


recommended for suspension by the CHMP on 22 January
2015

Some of these medicinal products may be considered critical by the individual EU Member States. The
suspension of the concerned marketing authorisation(s) may be deferred by the period for which the
medicinal product is considered critical.

Article 31 of Directive 2001/83/EC

Procedure number: EMEA/H/A-31/1408

30 Churchill Place Canary Wharf London E14 5EU United Kingdom


Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

Member State

Marketing Authorisation

(in EEA)

Holder

Austria

Arcana Arzneimittel GmbH

Esomeprazole

Esomeprazol Arcana 20 mg

Huetteldorfer Strae 299

magnesium

magensaftresistente

INN

1140 Wien

Invented name

Strength

20 mg

Pharmaceutical

Route of

Form

administration

Gastro - resistant

Oral use

capsule, hard

Hartkapseln

Austria
Austria

Arcana Arzneimittel GmbH

Esomeprazole

Esomeprazol Arcana 40 mg

Huetteldorfer Strae 299

magnesium

magensaftresistente

1140 Wien

40 mg

Gastro - resistant

Oral use

capsule, hard

Hartkapseln

Austria
Austria

Arcana Arzneimittel GmbH

Esomeprazole

Neximyl 20 mg

Huetteldorfer Strae 299

magnesium

magensaftresistente

1140 Wien

20 mg

Gastro - resistant

Oral use

capsule, hard

Hartkapseln

Austria
Austria

Arcana Arzneimittel GmbH

Esomeprazole

Neximyl 40 mg

Huetteldorfer Strae 299

magnesium

magensaftresistente

1140 Wien

40 mg

Gastro - resistant

Oral use

capsule, hard

Hartkapseln

Austria
Austria

Arcana Arzneimittel GmbH

Candesartan

Candesartan Arcana 4mg

Huetteldorfer Strae 299

cilexetil

Tabletten

Arcana Arzneimittel GmbH

Candesartan

Candesartan Arcana 8mg

Huetteldorfer Strae 299

cilexetil

Tabletten

4 mg

Tablet

Oral use

8mg

Tablet

Oral use

1140 Wien
Austria
Austria

1140 Wien
Austria

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Member State

Marketing Authorisation

(in EEA)

Holder

Austria

Arcana Arzneimittel GmbH

Candesartan

Candesartan Arcana 16mg

Huetteldorfer Strae 299

cilexetil

Tabletten

Arcana Arzneimittel GmbH

Candesartan

Candesartan Arcana 32mg

Huetteldorfer Strae 299

cilexetil

Tabletten

Nebivolol

Nebivolol Genericon 5 mg

INN

Invented name

Pharmaceutical

Route of

Form

administration

16 mg

Tablet

Oral use

32 mg

Tablet

Oral use

5 mg

Tablet

Oral use

2,5 mg

Orodispersible

Oral use

Strength

1140 Wien
Austria
Austria

1140 Wien
Austria
Austria

Genericon Pharma GmbH


Hafnerstr. 211

Tabletten

8054 Graz
Austria
Austria

ratiopharm Arzneimittei-

Desloratadine

Vertriebs-GmbH

Desloratadin ratiopharm
2,5 mg Schmelztabletten

tablet

Albert-Schweitzer-Gasse 3
1140 Wien
Austria
Austria

ratiopharm Arzneimittei-

Desloratadine

Vertriebs-GmbH

Desloratadin ratiopharm 5

5 mg

mg Schmelztabletten

Orodispersible

Oral use

tablet

Albert-Schweitzer-Gasse 3
1140 Wien
Austria
Belgium

Apotex Europe B.V.

Desloratadine

Desloratadine Apotex

Darwinweg 20

5 mg

Film - coated

Oral use

tablet

NL 2333 CR Leiden
Netherlands

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Member State

Marketing Authorisation

(in EEA)

Holder

Belgium

Mylan bvba/sprl

INN

Donepezil

Invented name

Donepezil Odis Mylan

Strength

5 mg

Terhulpsesteenweg 6A

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

1560 Hoeilaart
Belgium
Belgium

Mylan bvba/sprl

Donepezil

Donepezil Odis Mylan

10 mg

Terhulpsesteenweg 6A

Orodispersible

Oral use

tablet

1560 Hoeilaart
Belgium
Belgium

Mylan bvba/sprl

Repaglinide

Terhulpsesteenweg 6A

Repaglinide Mylan 0,5 mg

0,5 mg

Tablet

Oral use

1 mg

Tablet

Oral use

2 mg

Tablet

Oral use

8 mg

Tablet

Oral use

Pharma

1560 Hoeilaart
Belgium
Belgium

Mylan bvba/sprl

Repaglinide

Terhulpsesteenweg 6A

Repaglinide Mylan 1 mg
Pharma

1560 Hoeilaart
Belgium
Belgium

Mylan bvba/sprl

Repaglinide

Terhulpsesteenweg 6A

Repaglinide Mylan 2mg


Pharma

1560 Hoeilaart
Belgium
Belgium

Mylan bvba/sprl

Candesartan

Candesartan Mylan

Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium

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Member State

Marketing Authorisation

(in EEA)

Holder

Belgium

Mylan bvba/sprl

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Candesartan

Candesartan Mylan

16 mg

Tablet

Oral use

Candesartan

Candesartan Mylan

32 mg

Tablet

Oral use

Esomeprazole

Esomeprazole Mylan

20 mg

Gastro - resistant

Oral use

Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium
Belgium

Mylan bvba/sprl
Terhulpsesteenweg 6A
1560 Hoeilaart
Belgium

Belgium

Mylan bvba/sprl
Terhulpsesteenweg 6A

capsule, hard

1560 Hoeilaart
Belgium
Belgium

Mylan bvba/sprl

Esomeprazole

Esomeprazole Mylan

40 mg

Terhulpsesteenweg 6A

Gastro - resistant

Oral use

capsule, hard

1560 Hoeilaart
Belgium
Belgium

Takeda Belgium

Alendronic acid

Alendromono

70 mg

Tablet

Oral use

Desloratadine

Desloratadine Teva

2,5 mg

Orodispersible

Oral use

Gentsesteenweg 615
1080 Brussels
Belgium
Belgium

Teva Pharma Belgium NV


Laarstraat 16

tablet

2610 Wilrijk
Belgium

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Member State

Marketing Authorisation

(in EEA)

Holder

Belgium

Teva Pharma Belgium NV

INN

Desloratadine

Invented name

Desloratadine Teva

Strength

5 mg

Laarstraat 16

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

2610 Wilrijk
Belgium
Bulgaria

Accord Healthcare Limited

Ropinirole

Ropinirole Accord

0,5 mg

Sage House, 319 Pinner Road

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
Bulgaria

Accord Healthcare Limited

Ropinirole

Ropinirole Accord

1 mg

Sage House, 319 Pinner Road

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
Bulgaria

Accord Healthcare Limited

Ropinirole

Ropinirole Accord

2 mg

Sage House, 319 Pinner Road

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
Bulgaria

Accord Healthcare Limited

Ropinirole

Ropinirole Accord

Sage House, 319 Pinner Road

5 mg

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

Bulgaria

Alkaloid - INT d.o.o.

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Cefpodoxime

FOXERO

200 mg

Tablet

Oral use

Quetiapine

Aquatiapine

25 mg

Film - coated

Oral use

landrova 4
1231 Ljubljana - rnue
Slovenia
Bulgaria

Aquachim AD
blvd. Prof. Tsvetan Lazarov

tablet

83
Sofia 1582
Bulgaria
Bulgaria

Aquachim AD

Quetiapine

Aquatiapine

100 mg

blvd. Prof. Tsvetan Lazarov

Film - coated

Oral use

tablet

83
Sofia 1582
Bulgaria
Bulgaria

Aquachim AD

Quetiapine

Aquatiapine

200 mg

blvd. Prof. Tsvetan Lazarov

Film - coated

Oral use

tablet

83
Sofia 1582
Bulgaria
Bulgaria

Generics (UK) Ltd

Esomeprazole

Station Close, Potters Bar

magnesium

Esopragen

20 mg

Gastro - resistant

Oral use

capsule, hard

Hertfordshire, EN6 1TL


United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

Bulgaria

Generics (UK) Ltd

Esomeprazole

Station Close, Potters Bar

magnesium

INN

Invented name

Esopragen

Strength

40 mg

Pharmaceutical

Route of

Form

administration

Gastro - resistant

Oral use

capsule, hard

Hertfordshire, EN6 1TL


United Kingdom
Bulgaria

Glenmark Pharmaceuticals

Trimetazidine

s.r.o.

Apstar 35 mg

35 mg

prolonged-release tablets

Prolonged -

Oral use

release tablet

Hvzdova 1716/2b
14078 Praha 4
Czech Republic
Bulgaria

Mylan SAS

Trimetazidine

Trimetazigen MR

35 mg

117 alle des Parcs

Prolonged -

Oral use

release tablet

69792 Saint-Priest Cedex


France
Bulgaria

Neo Balkanika EOOD

Nebivolol

Bivolet

5 mg

Tablet

Oral use

Trimetazidine

Energotrim

35 mg

Prolonged -

Oral use

35 Zemliane Str.
Sofia 1618
Bulgaria
Bulgaria

Sandoz Pharmaceuticals d.d.


Verovskova 57

release tablet

Ljubljana SI-1000
Slovenia
Bulgaria

Tchaikapharma Highquality

Bosentan

Pulmohyperta

Medicines

62,5 mg

Film - coated

Oral use

tablet

1 G. M. Dimitrov Blvd.
Sofia 1172
Bulgaria

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Member State

Marketing Authorisation

(in EEA)

Holder

Bulgaria

Tchaikapharma Highquality

INN

Bosentan

Invented name

Pulmohyperta

Strength

125 mg

Medicines

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

1 G. M. Dimitrov Blvd.
Sofia 1172
Bulgaria
Croatia

Alkaloid d.o.o.

Cefpodoxime

Ulica grada Vukovara 226 F

Rexocef 200 mg filmom

200 mg

obloene tablete

Film - coated

Oral use

tablet

Zagreb 10000
Croatia
Croatia

Belupo, lijekovi i kozmetika

Desloratadine

d.d.

Alerdin 2,5 mg raspadljive

2,5 mg

tablete za usta

Orodispersible

Oral use

tablet

Ulica Danica 5
Koprivnica 48000
Croatia
Croatia

Belupo, lijekovi i kozmetika

Desloratadine

d.d.

Alerdin 5 mg raspadljive

5 mg

tablete za usta

Orodispersible

Oral use

tablet

Ulica Danica 5
Koprivnica 48000
Croatia
Croatia

Fidifarm d.o.o.
Obrtnika 37, Bestovje

Desloratadine

Sinalerg 5 mg filmom
obloene tablete

5 mg

Film - coated

Oral use

tablet

Rakitje 10437
Croatia

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Member State

Marketing Authorisation

(in EEA)

Holder

Croatia

Jadran Galenski Laboratorij

INN

Desloratadine

d.d.

Invented name

Escontral direkt 2,5 mg

Strength

2,5 mg

raspadljiva tableta za usta

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

Svilno 20, Rijeka


51000
Croatia
Croatia

Jadran Galenski Laboratorij

Desloratadine

d.d.

Escontral direkt 5 mg

5 mg

raspadljiva tableta za usta

Orodispersible

Oral use

tablet

Svilno 20, Rijeka


51000
Croatia
Croatia

Croatia

PharmaS d.o.o.

Tramadol/paraceta

Tramadol/Paracetamol

37,5

Film - coated

Radnika cesta 47

mol

PharmaS 37,5 mg/

mg/325 mg

tablet

10 mg

Film - coated

Zagreb 10000

325 mg filmom obloene

Croatia

tablete

PharmaS d.o.o.

Escitalopram

Escitalopram PharmaS 10

Radnika cesta 47

mg filmom

Zagreb 10000

obloene tablete

Oral use

Oral use

tablet

Croatia
Croatia

Sandoz d.o.o.

Trimetazidine

Vazidin 35 mg tablete s

Maksimirska 120

hydrochloride

produljenim oslobaanjem

35 mg

Prolonged -

Oral use

release tablet

Zagreb 10000
Croatia

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Member State

Marketing Authorisation

(in EEA)

Holder

Cyprus

Accord Healthcare Limited

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Alendronic acid

Alendronic Acid Accord

70 mg

Tablet

Oral use

Entacapone

Nobat

200 mg

Film - coated

Oral use

Sage House, 319 Pinner Road


North Harrow HA1 4HF
Middlesex
United Kingdom
Cyprus

Delorbis Pharmaceuticals Ltd


17 Athinon Street

tablet

Ergates Industrial Area


2643 Ergates
P.O. Box 28629
2081 Lefkosia
Cyprus
Cyprus

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Planckstrasse 13

orothiazide

Valsartan/Hctz Fair-med

DE-22765 Hamburg

160

Film - coated

mg/12,5

tablet

Oral use

mg

Germany
Cyprus

Generics Pharma Hellas Ltd

Donepezil

577a Vouliagmenis Avenue

hydrochloride

Donepezil/Generics

5 mg

Orodispersible

Oral use

tablet

Argyroupoli
164-51 Athens
Greece
Cyprus

Generics Pharma Hellas Ltd

Donepezil

577a Vouliagmenis Avenue

hydrochloride

Donepezil/Generics

10 mg

Orodispersible

Oral use

tablet

Argyroupoli
164-51 Athens
Greece

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Member State

Marketing Authorisation

(in EEA)

Holder

Cyprus

Lambda Therapeutic Limited

Ropinirole

Sage House

hydrochloride

INN

Invented name

Ropinirole Lambda

Strength

0,25 mg

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

319 Pinner Road, North


Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus

Lambda Therapeutic Limited

Ropinirole

Sage House

hydrochloride

Ropinirole Lambda

0,5 mg

Film - coated

Oral use

tablet

319 Pinner Road, North


Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus

Lambda Therapeutic Limited

Ropinirole

Sage House

hydrochloride

Ropinirole Lambda

1 mg

Film - coated

Oral use

tablet

319 Pinner Road, North


Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus

Lambda Therapeutic Limited

Ropinirole

Sage House

hydrochloride

Ropinirole Lambda

2 mg

Film - coated

Oral use

tablet

319 Pinner Road, North


Harrow
Middlesex HA1 4HF
United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

Cyprus

Lambda Therapeutic Limited

Ropinirole

Sage House

hydrochloride

INN

Invented name

Ropinirole Lambda

Strength

5 mg

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

319 Pinner Road, North


Harrow
Middlesex HA1 4HF
United Kingdom
Cyprus

Wockhardt UK Limited

Clopidogrel

Ash Road North

hydrochloride

Clopidogrel/Wockhardt

75 mg

Film - coated

Oral use

tablet

Wrexham Industrial Estate


Wrexham LL13 9UF
United Kingdom
Czech Republic

Abbott Laboratories, s.r.o.

Escitalopram

Evropsk 2591/33d

oxalate

Purcema 5 mg

5 mg

Film - coated

Oral use

tablet

160 00 Praha 6 - Hadovka


Office Park
Czech Republic
Czech Republic

Abbott Laboratories, s.r.o.

Escitalopram

Evropsk 2591/33d

oxalate

Purcema 10 mg

10 mg

Film - coated

Oral use

tablet

160 00 Praha 6 - Hadovka


Office Park
Czech Republic
Czech Republic

Abbott Laboratories, s.r.o.

Escitalopram

Evropsk 2591/33d

oxalate

Purcema 15 mg

15 mg

Film - coated

Oral use

tablet

160 00 Praha 6 - Hadovka


Office Park
Czech Republic

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Member State

Marketing Authorisation

(in EEA)

Holder

Czech Republic

Abbott Laboratories, s.r.o.

Escitalopram

Evropsk 2591/33d

oxalate

INN

Invented name

Purcema 20 mg

Strength

20 mg

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

160 00 Praha 6 - Hadovka


Office Park
Czech Republic
Czech Republic

Actavis Group PTC ehf.

Metformin

Metformin Actavis Retard

Reykjavikurvegi 76-78

hydrochloride

500 mg

Actavis Group PTC ehf.

Metformin

Metformin Actavis Retard

Reykjavikurvegi 76-78

hydrochloride

750 mg

Cefpodoxime

Forexo 200 mg potahovan

500 mg

Prolonged -

Oral use

release tablet

220 Hafnarfjrdur
Iceland
Czech Republic

750 mg

Prolonged -

Oral use

release tablet

220 Hafnarfjrdur
Iceland
Czech Republic

Alkaloid - INT d.o.o.


landrova 4

200 mg

tablety

Film - coated

Oral use

tablet

1231 Ljubljana - rnue


Slovenia
Czech Republic

Alvogen IPCo S.ar.l.

Desloratadine

Rue Heienhaff 5

Desloratadin Alvogen 5 mg

5 mg

potahovan tablety

Film - coated

Oral use

tablet

L-1736 Senningerberg
Luxembourg
Czech Republic

Apotex Europe B.V.

Trimetazidine

Darwinweg 20

dihydrochloride

Apo-trimetazidin 35 mg

35 mg

Prolonged -

Oral use

release tablet

NL 2333 CR Leiden
Netherlands

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Member State

Marketing Authorisation

(in EEA)

Holder

Czech Republic

Generics (UK) Ltd

Esomeprazole

Station Close, Potters Bar

magnesium

INN

Invented name

Esomylan 40 mg

Strength

40 mg

Pharmaceutical

Route of

Form

administration

Gastro - resistant

Oral use

capsule, hard

Hertfordshire, EN6 1TL


United Kingdom
Czech Republic

Generics (UK) Ltd

Rizatriptan

Station Close, Potters Bar

benzoate

Rizatriptan Mylan 5 mg

5 mg

Orodispersible

Oral use

tablet

Hertfordshire, EN6 1TL


United Kingdom
Czech Republic

Generics (UK) Ltd

Rizatriptan

Station Close, Potters Bar

benzoate

Rizatriptan Mylan 10 mg

10 mg

Orodispersible

Oral use

tablet

Hertfordshire, EN6 1TL


United Kingdom
Czech Republic

Generics (UK) Ltd

Donepezil

Station Close, Potters Bar

hydrochloride

Donepezil Mylan 10 mg

10 mg

Orodispersible

Oral use

tablet

Hertfordshire, EN6 1TL


United Kingdom
Czech Republic

Glenmark Pharmaceuticals

Trimetazidine

Portora 35 mg tablety s

s.r.o.

dihydrochloride

prodlouenm uvolovnm

Desloratadine

Geslora 5 mg

35 mg

Prolonged -

Oral use

release tablet

Hvzdova 1716/2b
14078 Praha 4
Czech Republic
Czech Republic

GNR Czech s.r.o.


Slavojova 579/9

5 mg

Film - coated

Oral use

tablet

128 00 Praha 2
Czech Republic

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Member State

Marketing Authorisation

(in EEA)

Holder

Czech Republic

Labormed-Pharma, SA

INN

Desloratadine

Invented name

Desloratadin Labormed 2,5

Theodor Pallady, 44B

mg tablety dispergovateln

032266 Bucharest

v stech

Strength

2,5 mg

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

Romania
Czech Republic

Labormed-Pharma, SA

Desloratadine

Desloratadin Labormed 5

Theodor Pallady, 44B

mg tablety dispergovateln

032266 Bucharest

v stech

5 mg

Orodispersible

Oral use

tablet

Romania
Czech Republic

Mylan SAS

Trimetazidine

Trimetazidin Mylan 35 mg

35 mg

117 alle des Parcs

Prolonged -

Oral use

release tablet

69792 Saint-Priest Cedex


France
Czech Republic

SVUS Pharma a.s.

Desloratadine

Smetanovo nbe 1238/20a

Lotera 5 mg potahovan

5 mg

tablety

Film - coated

Oral use

tablet

500 02 Hradec Krlov


Czech Republic
Denmark

Actavis Group PTC ehf.

Metformin

Metformin "Actavis PTC"

500 mg

Reykjavikurvegi 76-78

Prolonged -

Oral use

release tablet

220 Hafnarfjrdur
Iceland
Denmark

Actavis Group PTC ehf.

Metformin

Metformin "Actavis PTC"

Reykjavikurvegi 76-78

750 mg

Prolonged -

Oral use

release tablet

220 Hafnarfjrdur
Iceland

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Member State

Marketing Authorisation

(in EEA)

Holder

Denmark

Bluefish Pharmaceuticals AB

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Fluconazole

Fluconazol "Bluefish"

50 mg

Capsule, hard

Oral use

Fluconazole

Fluconazol "Bluefish"

150 mg

Capsule, hard

Oral use

Fluconazole

Fluconazol "Bluefish"

200 mg

Capsule, hard

Oral use

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/hydrochlorthiazid

160

Film - coated

Oral use

Planckstrasse 13

orothiazide

"Fair-Med"

mg/12,5

tablet

Torsgatan 11
SE-11123 Stockholm
Sweden
Denmark

Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden

Denmark

Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden

Denmark

DE-22765 Hamburg

mg

Germany
Denmark

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/hydrochlorthiazid

320

Film - coated

Planckstrasse 13

orothiazide

"Fair-Med"

mg/12,5

tablet

DE-22765 Hamburg

Oral use

mg

Germany
Denmark

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/hydrochlorthiazid

320 mg/25

Film - coated

Planckstrasse 13

orothiazide

"Fair-Med"

mg

tablet

Oral use

DE-22765 Hamburg
Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 17/131

Member State

Marketing Authorisation

(in EEA)

Holder

Denmark

Mylan AB

INN

Eletriptan

Invented name

Eletriptan Mylan

Strength

40 mg

PO Box 230 33

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

SE-104 35 Stockholm
Sweden
Denmark

Mylan AB

Esomeprazole

Esomeprazol Mylan

20 mg

PO Box 230 33

Gastro - resistant

Oral use

capsule, hard

SE-104 35 Stockholm
Sweden
Denmark

Mylan AB

Esomeprazole

Esomeprazol Mylan

40 mg

PO Box 230 33

Gastro - resistant

Oral use

capsule, hard

SE-104 35 Stockholm
Sweden
Denmark

Mylan AB

Rizatriptan

Rizatriptan Mylan

10 mg

PO Box 230 33

Orodispersible

Oral use

tablet

SE-104 35 Stockholm
Sweden
Denmark

Stadapharm GmbH

Entacapone

Entacapon STADA

200 mg

Stadastr. 2-18

Film - coated

Oral use

tablet

D-61118 Bad Vilbel


Germany
Estonia

Accord Healthcare Limited


Sage House, 319 Pinner Road

Alendronic acid

ALENDRONIC ACID

70 mg

Tablet

Oral use

ACCORD 70mg

North Harrow HA1 4HF


Middlesex
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Estonia

Sandoz Pharmaceuticals d.d.

INN

Trimetazidine

Invented name

ZIDMETIN

Strength

35 mg

Verovskova 57

Pharmaceutical

Route of

Form

administration

Modified - release

Oral use

tablet

Ljubljana SI-1000
Slovenia
Finland

Actavis Group PTC ehf.

Metformin

Metformin Actavis

500 mg

Reykjavikurvegi 76-78

Prolonged -

Oral use

release tablet

220 Hafnarfjrdur
Iceland
Finland

Actavis Group PTC ehf.

Metformin

Metformin Actavis

750 mg

Reykjavikurvegi 76-78

Prolonged -

Oral use

release tablet

220 Hafnarfjrdur
Iceland
Finland

Bluefish Pharmaceuticals AB

Fluconazole

Fluconazol Bluefish

50 mg

Capsule, hard

Oral use

Fluconazole

Fluconazol Bluefish

150 mg

Capsule, hard

Oral use

Fluconazole

Fluconazol Bluefish

200 mg

Capsule, hard

Oral use

Torsgatan 11
SE-11123 Stockholm
Sweden
Finland

Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden

Finland

Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden

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Member State

Marketing Authorisation

(in EEA)

Holder

Finland

Mylan AB

INN

Eletriptan

Invented name

Eletriptan Mylan

Strength

40 mg

PO Box 230 33

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

SE-104 35 Stockholm
Sweden
Finland

Mylan AB

Repaglinide

Repaglinid Mylan

0,5 mg

Tablet

Oral use

Repaglinide

Repaglinid Mylan

1 mg

Tablet

Oral use

Repaglinide

Repaglinid Mylan

2 mg

Tablet

Oral use

Valsartan

VALSARTAN ORION

40 mg

Film - coated

Oral use

PO Box 230 33
SE-104 35 Stockholm
Sweden
Finland

Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden

Finland

Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden

Finland

Orion Corporation
Orion Pharma

tablet

PO BOX 65
02101 Espoo
Finland
Finland

Orion Corporation

Valsartan

VALSARTAN ORION

Orion Pharma

80 mg

Film - coated

Oral use

tablet

PO BOX 65
02101 Espoo
Finland

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Finland

Orion Corporation

INN

Valsartan

Invented name

VALSARTAN ORION

Strength

160 mg

Orion Pharma

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

PO BOX 65
02101 Espoo
Finland
Finland

Orion Corporation

Valsartan

VALSARTAN ORION

320 mg

Orion Pharma

Film - coated

Oral use

tablet

PO BOX 65
02101 Espoo
Finland
Finland

ratiopharm GmbH

Desloratadine

Desloratadine Ratiopharm

2,5 mg

Graf-Arco-Strasse 3

Orodispersible

Oral use

tablet

D-89079 Ulm
Germany
Finland

ratiopharm GmbH

Desloratadine

Desloratadine Ratiopharm

5 mg

Graf-Arco-Strasse 3

Orodispersible

Oral use

tablet

D-89079 Ulm
Germany
France

Abbott Products SAS

Escitalopram

42 rue Rouget de Lisle

ESCITALOPRAM ABBOTT

5 mg

5mg, comprim pellicul

Film - coated

Oral use

tablet

92150 Suresnes
France
France

Abbott Products SAS


42 rue Rouget de Lisle

Escitalopram

ESCITALOPRAM ABBOTT
10mg, comprim pellicul

10 mg

Film - coated

Oral use

tablet

92150 Suresnes
France

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Member State

Marketing Authorisation

(in EEA)

Holder

France

Abbott Products SAS

INN

Escitalopram

42 rue Rouget de Lisle

Invented name

ESCITALOPRAM ABBOTT

Strength

15 mg

15mg, comprim pellicul

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

92150 Suresnes
France
France

Abbott Products SAS

Escitalopram

42 rue Rouget de Lisle

ESCITALOPRAM ABBOTT

20 mg

20mg, comprim pellicul

Film - coated

Oral use

tablet

92150 Suresnes
France
France

ACCORD HEALTHCARE France

Ropinirole

SAS

Ropinirole Accord 0,25mg,

0,25 mg

comprim pellicul

Film - coated

Oral use

tablet

45 Rue de Fbg de Roubaix


59000 Lille
France
France

ACCORD HEALTHCARE France

Ropinirole

SAS

Ropinirole Accord 0,5mg,

0,5 mg

comprim pellicul

Film - coated

Oral use

tablet

45 Rue de Fbg de Roubaix


59000 Lille
France
France

ACCORD HEALTHCARE France


SAS

Ropinirole

Ropinirole Accord 1mg,


comprim pellicul

1 mg

Film - coated

Oral use

tablet

45 Rue de Fbg de Roubaix


59000 Lille
France

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Member State

Marketing Authorisation

(in EEA)

Holder

France

ACCORD HEALTHCARE France

INN

Ropinirole

SAS

Invented name

Ropinirole Accord 2mg,

Strength

2 mg

comprim pellicul

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

45 Rue de Fbg de Roubaix


59000 Lille
France
France

ACCORD HEALTHCARE France

Ropinirole

SAS

Ropinirole Accord 5mg,

5 mg

comprim pellicul

Film - coated

Oral use

tablet

45 Rue de Fbg de Roubaix


59000 Lille
France
France

Brown & Burk UK, Ltd.

Escitalopram

ESCITALOPRAM BROWN 5

5, Marryat Close

mg, comprim pellicul

Hounslow

scable

5 mg

Film - coated

Oral use

tablet

TW4 5DQ Middlesex


United Kingdom
France

Brown & Burk UK, Ltd.

Escitalopram

ESCITALOPRAM BROWN 10

5, Marryat Close

mg, comprim pellicul

Hounslow

scable

10 mg

Film - coated

Oral use

tablet

TW4 5DQ Middlesex


United Kingdom
France

Brown & Burk UK, Ltd.

Escitalopram

ESCITALOPRAM BROWN 15

5, Marryat Close

mg, comprim pellicul

Hounslow

scable

15 mg

Film - coated

Oral use

tablet

TW4 5DQ Middlesex


United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

France

Brown & Burk UK, Ltd.

INN

Escitalopram

Invented name

ESCITALOPRAM BROWN 20

5, Marryat Close

mg, comprim pellicul

Hounslow

scable

Strength

20 mg

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

TW4 5DQ Middlesex


United Kingdom
France

Brown & Burk UK, Ltd.

Ebastine

EBASTINE BROWN & BURK

5, Marryat Close

10 mg, comprim

Hounslow

orodispersible

10 mg

Orodispersible

Oral use

tablet

TW4 5DQ Middlesex


United Kingdom
France

France

Cristers

Desloratadine

DESLORATADINE

22, quai Gallini

CRISTERS

92150 Suresnes

5 mg

France

comprim pellicul

Cristers

Ibuprofen

IBUPROFENE CRISTERS

22, quai Gallini

400 mg

92150 Suresnes

comprim pellicul

5 mg

Film - coated

Oral use

tablet

400 mg

Film - coated

Oral use

tablet

France
France

Laboratoires Biogaran
15, boulevard Charles de

Ebastine

EBASTINE BIOGARAN 10
mg comprim pellicul

10 mg

Film - coated

Oral use

tablet

Gaulle
92707 Colombes Cedex
France

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

France

Laboratoires Biogaran

INN

Ebastine

Invented name

EBASTINE BIOGARAN 10

15, boulevard Charles de

mg comprim

Gaulle

orodispersible

Strength

10 mg

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

92707 Colombes Cedex


France
France

Laboratoires GERDA

Desloratadine

DESLORATADINE ARROW

24 rue Erlanger

5 mg

75016 PARIS

comprim pellicul

5 mg

Film - coated

Oral use

tablet

France
France

Medipha Sante

Tramadol/paraceta

TRAMADOL PARACETAMOL

37,5

Film - coated

Les Fjords - Immeuble Oslo

mol

NIALEX 37,5 mg/325 mg

mg/325 mg

tablet

5 mg

Film - coated

19 avenue de Norvge

Oral use

comprim pellicul

91953 Courtaboeuf Cedex


France
France

Medipha Sante

Desloratadine

DESLORATADINE GNR

Les Fjords - Immeuble Oslo

5 mg

19 avenue de Norvge

comprim pellicul

Oral use

tablet

91953 Courtaboeuf Cedex


France
France

Mylan SAS
117 alle des Parcs

Rizatriptan

RIZATRIPTAN MYLAN 5mg,


orodispersible tablet

5 mg

Orodispersible

Oral use

tablet

69792 Saint-Priest Cedex


France

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Member State

Marketing Authorisation

(in EEA)

Holder

France

Mylan SAS

INN

Rizatriptan

117 alle des Parcs

Invented name

RIZATRIPTAN MYLAN 10

Strength

10 mg

mg, orodispersible tablet

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

69792 Saint-Priest Cedex


France
France

Mylan SAS

Ebastine

117 alle des Parcs

EBASTINE MYLAN 10mg,

10 mg

film-coated tablet

Film - coated

Oral use

tablet

69792 Saint-Priest Cedex


France
France

Mylan SAS

Ebastine

117 alle des Parcs

EBASTINE MYLAN 10mg,

10 mg

orodispersible tablet

Orodispersible

Oral use

tablet

69792 Saint-Priest Cedex


France
France

Mylan SAS

Trimetazidine

TRIMETAZIDINE MYLAN 35

117 alle des Parcs

mg Modified Release

69792 Saint-Priest Cedex

Tablets

35 mg

Modified - release

Oral use

tablet

France
France

Mylan SAS

Candesartan

117 alle des Parcs

CANDESARTAN MYLAN 32

32 mg

Tablet

Oral use

5 mg

Orodispersible

Oral use

mg, comprim secable

69792 Saint-Priest Cedex


France
France

Mylan SAS
117 alle des Parcs

Donepezil

DONEPEZIL MYLAN 5 mg,


orodispersible tablet

tablet

69792 Saint-Priest Cedex


France

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

France

Mylan SAS

INN

Donepezil

117 alle des Parcs

Invented name

DONEPEZIL MYLAN 10

Strength

10 mg

mg, orodispersible tablet

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

69792 Saint-Priest Cedex


France
France

Mylan SAS

Esomeprazole

117 alle des Parcs

ESOMEPRAZOLE MYLAN

20 mg

PHARMA 20mg, DR capsule

Gastro - resistant

Oral use

capsule, hard

69792 Saint-Priest Cedex


France
France

Mylan SAS

Esomeprazole

117 alle des Parcs

ESOMEPRAZOLE MYLAN

40 mg

PHARMA 40mg, DR capsule

Gastro - resistant

Oral use

capsule, hard

69792 Saint-Priest Cedex


France
France

Mylan SAS

Desmopressin

117 alle des Parcs

DESMOPRESSINE MYLAN

0,06 mg

60 g, orodispersible tablet

Orodispersible

Oral use

tablet

69792 Saint-Priest Cedex


France
France

Mylan SAS

Desmopressin

DESMOPRESSINE MYLAN

117 alle des Parcs

120 g, orodispersible

69792 Saint-Priest Cedex

tablet

0,12 mg

Orodispersible

Oral use

tablet

France
France

Mylan SAS

Desmopressin

DESMOPRESSINE MYLAN

117 alle des Parcs

240 g, orodispersible

69792 Saint-Priest Cedex

tablet

0,24 mg

Orodispersible

Oral use

tablet

France

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EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

France

Ranbaxy Pharmacie

INN

Aciclovir

Generiques

Invented name

Aciclovir Ranbaxy 800 mg,

Pharmaceutical

Route of

Form

administration

800 mg

Tablet

Oral use

200 mg

Tablet

Oral use

200 mg

Tablet

Oral use

70 mg

Tablet

Oral use

10 mg

Film - coated

Oral use

Strength

comprim

11-15 Quai Dion Bouton


92800 Puteaux
France
France

Ranbaxy Pharmacie

Aciclovir

Generiques

Aciclovir Ranbaxy 200 mg,


comprim

11-15 Quai Dion Bouton


92800 Puteaux
France
France

Ranbaxy Pharmacie

Aciclovir

Generiques

Aciclovir Almus 200 mg,


comprim

11-15 Quai Dion Bouton


92800 Puteaux
France
France

Ranbaxy Pharmacie

Alendronic acid

Generiques

Acide Alendronique
Ranbaxy 70 mg, comprim

11-15 Quai Dion Bouton


92800 Puteaux
France
France

Sanofi Aventis France


1-13 bd Romain Rolland

Ebastine

EBASTINE ZENTIVA 10 mg
comprim pellicul

tablet

75159 Paris Cedex 14


France

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

France

Sanofi Aventis France

INN

Ebastine

1-13 bd Romain Rolland

Invented name

EBASTINE ZENTIVA 10 mg

Strength

10 mg

comprim orodispersible

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

75159 Paris Cedex 14


France
France

Teva Sante

Desloratadine

DESLORATADINE TEVA

Cur Dfense - 100-110

SANTE

Esplanade du Gnral de

5 mg

Gaulle

comprim pellicul

5 mg

Film - coated

Oral use

tablet

92931 La Dfense Cedex


France
France

Venipharm SAS

Ebastine

4 Bureaux de la Colline

EBOUDA 10 mg comprim

10 mg

pellicul

Film - coated

Oral use

tablet

92213 Saint-Cloud
France
France

Venipharm SAS

Ebastine

4 Bureaux de la Colline

EBARREN 10 mg comprim

10 mg

pellicul

Film - coated

Oral use

tablet

92213 Saint-Cloud
France
France

Venipharm SAS

Ebastine

4 Bureaux de la Colline

EBONDE 10 mg comprim

10 mg

pellicul

Film - coated

Oral use

tablet

92213 Saint-Cloud
France
France

Venipharm SAS
4 Bureaux de la Colline

Ebastine

EBONTAN 10 mg comprim
orodispersible

10 mg

Orodispersible

Oral use

tablet

92213 Saint-Cloud
France

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

France

Venipharm SAS

INN

Ebastine

4 Bureaux de la Colline

Invented name

Strength

EBACHOI 10 mg comprim

10 mg

orodispersible

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

92213 Saint-Cloud
France
France

Venipharm SAS

Ibuprofen

IBUPROFENE ZYDUS

4 Bureaux de la Colline

FRANCE 200 mg comprim

92213 Saint-Cloud

pellicul

200 mg

Film - coated

Oral use

tablet

France
France

Zydus France

Ibuprofen

IBUPROFENE ZYDUS

Zacles Hautes Patures

FRANCE 400 mg comprim

25 Rue des Peupliers

pellicul

400 mg

Film - coated

Oral use

tablet

92752 Nanterre Cedes


France
France

Zydus France

Tramadol/paraceta

TRAMADOL PARACETAMOL

37,5

Film - coated

Zacles Hautes Patures

mol

ZYDUS FRANCE

mg/325 mg

tablet

400 mg

Film - coated

37,5

25 Rue des Peupliers

mg/325 mg comprim

92752 Nanterre Cedes

pellicul

Oral use

France
France

Zydus France
Zacles Hautes Patures

Ibuprofen

IBUPROFENE ZF 400 mg
comprim pellicul

Oral use

tablet

25 Rue des Peupliers


92752 Nanterre Cedes
France

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

France

Zydus France

INN

Desloratadine

Zacles Hautes Patures

Invented name

DESLORATADINE ZYDUS 5

Strength

5 mg

mg comprim pellicul

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

25 Rue des Peupliers


92752 Nanterre Cedes
France
France

Zydus France

Escitalopram

Zacles Hautes Patures

ESCITALOPRAM ZYDUS 5

5 mg

mg, comprim pellicul

Film - coated

Oral use

tablet

25 Rue des Peupliers


92752 Nanterre Cedes
France
France

Zydus France

Escitalopram

ESCITALOPRAM ZYDUS 10

Zacles Hautes Patures

mg, comprim pellicul

25 Rue des Peupliers

scable

10 mg

Film - coated

Oral use

tablet

92752 Nanterre Cedes


France
France

Zydus France

Escitalopram

ESCITALOPRAM ZYDUS 15

Zacles Hautes Patures

mg, comprim pellicul

25 Rue des Peupliers

scable

15 mg

Film - coated

Oral use

tablet

92752 Nanterre Cedes


France

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

France

Zydus France

INN

Escitalopram

Invented name

ESCITALOPRAM ZYDUS 20

Zacles Hautes Patures

mg, comprim pellicul

25 Rue des Peupliers

scable

Strength

20 mg

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

92752 Nanterre Cedes


France
Germany

Accord Healthcare Limited

Alendronic acid

Sage House, 319 Pinner Road

ALENDRONIC ACID

70 mg

Tablet

Oral use

250 mg

Film - coated

Oral use

ACCORD 70MG

North Harrow HA1 4HF


Middlesex
United Kingdom
Germany

betapharm Arzneimittel GmbH

Levetiracetam

Kobelweg 95

Levetiracetam beta 250


mg, Filmtabletten

tablet

D-86156 Augsburg
Germany
Germany

betapharm Arzneimittel GmbH

Levetiracetam

Kobelweg 95

Levetiracetam beta 500

500 mg

mg, Filmtabletten

Film - coated

Oral use

tablet

D-86156 Augsburg
Germany
Germany

betapharm Arzneimittel GmbH

Levetiracetam

Kobelweg 95

Levetiracetam beta 750

750 mg

mg, Filmtabletten

Film - coated

Oral use

tablet

D-86156 Augsburg
Germany
Germany

betapharm Arzneimittel GmbH


Kobelweg 95

Levetiracetam

Levetiracetam beta 1000


mg, Filmtabeltten

1000 mg

Film - coated

Oral use

tablet

D-86156 Augsburg
Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Germany

Fair-Med Healthcare GmbH

INN

Irbesartan

Planckstrasse 13

Invented name

Irbesartan Tablets

Strength

75 mg

75mg

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany
Germany

Fair-Med Healthcare GmbH

Irbesartan

Planckstrasse 13

Irbesartan Tablets

150 mg

150mg

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany
Germany

Fair-Med Healthcare GmbH

Irbesartan

Planckstrasse 13

Irbesartan Tablets

300 mg

300 mg

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany
Germany

Fair-Med Healthcare GmbH

Irbesartan/hydroch

Irbesartan HCTZ Fair-Med

150

Film - coated

Planckstrasse 13

lorothiazide

150+12,5 mg Filmtabletten

mg/12,5

tablet

DE-22765 Hamburg

Oral use

mg

Germany
Germany

Fair-Med Healthcare GmbH

Irbesartan/hydroch

Irbesartan HCTZ Fair-Med

300

Film - coated

Planckstrasse 13

lorothiazide

300+12,5 mg Filmtabletten

mg/12,5

tablet

DE-22765 Hamburg

Oral use

mg

Germany
Germany

Fair-Med Healthcare GmbH

Irbesartan/hydroch

Planckstrasse 13

lorothiazide

Irbesartan HCTZ Fair-Med


300+25 mg Filmtabletten

300 mg/25

Film - coated

mg

tablet

Oral use

DE-22765 Hamburg
Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Germany

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/HCTZ Fair-Med

Planckstrasse 13

orothiazide

INN

DE-22765 Hamburg

Pharmaceutical

Route of

Form

administration

160

Film - coated

Oral use

Healthcare 160 mg/12.5

mg/12,5

tablet

mg Filmtabletten

mg

Invented name

Strength

Germany
Germany

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/HCTZ Fair-Med

320

Film - coated

Planckstrasse 13

orothiazide

Healthcare 320 mg/12,5

mg/12,5

tablet

mg Filmtabletten

mg

DE-22765 Hamburg

Oral use

Germany
Germany

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/HCTZ Fair-Med

320 mg/25

Film - coated

Planckstrasse 13

orothiazide

Healthcare 320 mg/25 mg

mg

tablet

37,5 mg

Prolonged -

DE-22765 Hamburg

Oral use

Filmtabletten

Germany
Germany

Fair-Med Healthcare GmbH

Venlafaxine

Planckstrasse 13

Venlafaxin Fair-Med 37,5


mg Hartkapseln, retardiert

Oral use

release capsule,

DE-22765 Hamburg

hard

Germany
Germany

Fair-Med Healthcare GmbH

Venlafaxine

Planckstrasse 13

Venlafaxin Fair-Med 75 mg

75 mg

Hartkapseln, retardiert

Prolonged -

Oral use

release capsule,

DE-22765 Hamburg

hard

Germany
Germany

Fair-Med Healthcare GmbH


Planckstrasse 13

Venlafaxine

Venlafaxin Fair-Med 150


mg Hartkapseln, retardiert

DE-22765 Hamburg

150 mg

Prolonged -

Oral use

release capsule,
hard

Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 34/131

Member State

Marketing Authorisation

(in EEA)

Holder

Germany

Fair-Med Healthcare GmbH

INN

Ciprofloxacin

Invented name

Ciprofloxacin Fair-Med

Planckstrasse 13

Healthcare 500 mg

DE-22765 Hamburg

Filmtabletten

Strength

500 mg

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

Germany
Germany

Fair-Med Healthcare GmbH

Ciprofloxacin

Ciprofloxacin Fair-Med

Planckstrasse 13

Healthcare 750 mg

DE-22765 Hamburg

Filmtabletten

750 mg

Film - coated

Oral use

tablet

Germany
Germany

Fair-Med Healthcare GmbH

Ciprofloxacin

Ciprofloxacin Fair-Med

Planckstrasse 13

Healthcare 250 mg

DE-22765 Hamburg

Filmtabletten

250 mg

Film - coated

Oral use

tablet

Germany
Germany

Heumann Pharma GmbH &

Irbesartan

Co. Generica KG

Irbesartan Heumann 75

75 mg

mg Filmtabletten

Film - coated

Oral use

tablet

Sdwestpark 50
90449 Nrnberg
Germany
Germany

Heumann Pharma GmbH &


Co. Generica KG

Irbesartan

Irbesartan Heumann 150


mg Filmtabletten

150 mg

Film - coated

Oral use

tablet

Sdwestpark 50
90449 Nrnberg
Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 35/131

Member State

Marketing Authorisation

(in EEA)

Holder

Germany

Heumann Pharma GmbH &

INN

Irbesartan

Co. Generica KG

Invented name

Irbesartan Heumann 300

Strength

300 mg

mg Filmtabletten

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

Sdwestpark 50
90449 Nrnberg
Germany
Germany

Heumann Pharma GmbH &

Irbesartan/hydroch

Irbesartan/Hydrochlorothia

150

Film - coated

Co. Generica KG

lorothiazide

zid Heumann 150 mg/12.5

mg/12,5

tablet

mg Filmtabletten

mg

Sdwestpark 50

Oral use

90449 Nrnberg
Germany
Germany

Heumann Pharma GmbH &

Irbesartan/hydroch

Irbesartan/Hydrochlorothia

300

Film - coated

Co. Generica KG

lorothiazide

zid Heumann 300 mg/12.5

mg/12,5

tablet

mg Filmtabletten

mg

Sdwestpark 50

Oral use

90449 Nrnberg
Germany
Germany

Heumann Pharma GmbH &

Irbesartan/hydroch

Irbesartan/Hydrochlorothia

300 mg/25

Film - coated

Co. Generica KG

lorothiazide

zid Heumann 300 mg/25

mg

tablet

200 mg

Film - coated

Sdwestpark 50

Oral use

mg Filmtabletten

90449 Nrnberg
Germany
Germany

Hormosan Pharma GmbH

Cefpodoxime

Cefpodoxim-

Wilhelmshoeher Str. 106

proxetil

Hormosan

D-60389 Frankfurt

200mg

06 Hessen

Filmtabletten

Oral use

tablet

Germany
GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 36/131

Member State

Marketing Authorisation

(in EEA)

Holder

Germany

Lupin (Europe) Limited

Trimetazidine

Lupamadazine 35 mg

Victoria Court, Bexton Road

hydrochloride

Retardtabletten

Escitalopram

Escitalopram-Micro Labs 5

INN

Invented name

Strength

35 mg

Pharmaceutical

Route of

Form

administration

Controlled -

Oral use

release tablet

Knutsford, Cheshire WA16


0PF
United Kingdom
Germany

Micro Labs GmbH


Lyoner Str. 14

5 mg

mg Filmtabletten

Film - coated

Oral use

tablet

D-60528 Frankfurt/Main
Germany
Germany

Micro Labs GmbH

Escitalopram

Lyoner Str. 14

Escitalopram-Micro Labs 10

10 mg

mg Filmtabletten

Film - coated

Oral use

tablet

D-60528 Frankfurt/Main
Germany
Germany

Micro Labs GmbH

Escitalopram

Lyoner Str. 14

Escitalopram-Micro Labs 15

15 mg

mg Filmtabletten

Film - coated

Oral use

tablet

D-60528 Frankfurt/Main
Germany
Germany

Micro Labs GmbH

Escitalopram

Lyoner Str. 14

Escitalopram-Micro Labs 20

20 mg

mg Filmtabletten

Film - coated

Oral use

tablet

D-60528 Frankfurt/Main
Germany
Germany

Mylan dura GmBh


Wittichstrasse 6

Repaglinide

Repaglinid Mylan 0,5 mg

0,5 mg

Tablet

Oral use

Tabletten

64295 Darmstadt
Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 37/131

Member State

Marketing Authorisation

(in EEA)

Holder

Germany

Mylan dura GmBh

INN

Repaglinide

Wittichstrasse 6

Invented name

Repaglinid Mylan 1 mg

Pharmaceutical

Route of

Form

administration

1 mg

Tablet

Oral use

2 mg

Tablet

Oral use

5 mg

Orodispersible

Oral use

Strength

Tabletten

64295 Darmstadt
Germany
Germany

Mylan dura GmBh

Repaglinide

Wittichstrasse 6

Repaglinid Mylan 2 mg
Tabletten

64295 Darmstadt
Germany
Germany

Mylan dura GmBh

Rizatriptan

Wittichstrasse 6

Rizatriptan Mylan dura 5


mg Schmelztabletten

tablet

64295 Darmstadt
Germany
Germany

Mylan dura GmBh

Rizatriptan

Wittichstrasse 6

Rizatriptan Mylan dura 10

10 mg

mg Schmelztabletten

Orodispersible

Oral use

tablet

64295 Darmstadt
Germany
Germany

Panacea Biotec Germany

Tacrolimus

Tacpan 0.5 mg Hartkapseln

0,5 mg

Capsule, hard

Oral use

Tacrolimus

Tacpan 1 mg Hartkapseln

1 mg

Capsule, hard

Oral use

GmbH
Landshuter Allee 8-10
D-80637 Mnchen
Germany
Germany

Panacea Biotec Germany


GmbH
Landshuter Allee 8-10
D-80637 Mnchen
Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 38/131

Member State

Marketing Authorisation

(in EEA)

Holder

Germany

Panacea Biotec Germany

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Tacrolimus

Tacpan 5 mg Hartkapseln

5 mg

Capsule, hard

Oral use

Entacapone

Entacapon STADA 200 mg

200 mg

Film - coated

Oral use

GmbH
Landshuter Allee 8-10
D-80637 Mnchen
Germany
Germany

Stadapharm GmbH
Stadastr. 2-18

Filmtabletten

tablet

D-61118 Bad Vilbel


Germany
Germany

Unichem Laboratories Ltd.

Irbesartan

Studio 8B Ard Gaoithe

Irbesartan Unichem 150

150 mg

mg Filmtabletten

Film - coated

Oral use

tablet

Commercial Centre, Business


Park
Cashel Road Clonmel,
Co Tipperary
Ireland
Germany

Unichem Laboratories Ltd.


Studio 8B Ard Gaoithe

Irbesartan

Irbesartan Unichem 300


mg Filmtabletten

300 mg

Film - coated

Oral use

tablet

Commercial Centre, Business


Park
Cashel Road Clonmel,
Co Tipperary
Ireland

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 39/131

Member State

Marketing Authorisation

(in EEA)

Holder

Germany

Welding GmbH & Co. KG

Irbesartan/hydroch

Irbesartan +

Esplanade 39

lorothiazide

Hidroclorotiazida Welding

INN

Invented name

D-20354 Hamburg

Pharmaceutical

Route of

Form

administration

300

Film - coated

Oral use

mg/12,5

tablet

Strength

mg

Germany
Germany

Welding GmbH & Co. KG

Irbesartan/hydroch

Irbesartan +

150

Film - coated

Esplanade 39

lorothiazide

Hidroclorotiazida Welding

mg/12,5

tablet

D-20354 Hamburg

Oral use

mg

Germany
Germany

Welding GmbH & Co. KG

Irbesartan/hydroch

Irbesartan +

300 mg/25

Film - coated

Esplanade 39

lorothiazide

Hidroclorotiazida Welding

mg

tablet

Irbesartan

Irbesartan Welding

75 mg

Film - coated

Oral use

D-20354 Hamburg
Germany
Germany

Welding GmbH & Co. KG


Esplanade 39

Oral use

tablet

D-20354 Hamburg
Germany
Germany

Welding GmbH & Co. KG

Irbesartan

Irbesartan Welding

150 mg

Esplanade 39

Film - coated

Oral use

tablet

D-20354 Hamburg
Germany
Germany

Welding GmbH & Co. KG

Irbesartan

Irbesartan Welding

Esplanade 39

300 mg

Film - coated

Oral use

tablet

D-20354 Hamburg
Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 40/131

Member State

Marketing Authorisation

(in EEA)

Holder

Greece

Abbott Laboratories

Escitalopram

Hellas

oxalate

INN

Invented name

Savandra

Strength

5 mg

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

Agiou Dimitriou 63
Alimos 17456
Greece
Greece

Abbott Laboratories

Escitalopram

Hellas

oxalate

Savandra

10 mg

Film - coated

Oral use

tablet

Agiou Dimitriou 63
Alimos 17456
Greece
Greece

Abbott Laboratories

Escitalopram

Hellas

oxalate

Savandra

15 mg

Film - coated

Oral use

tablet

Agiou Dimitriou 63
Alimos 17456
Greece
Greece

Abbott Laboratories

Escitalopram

Hellas

oxalate

Savandra

20 mg

Film - coated

Oral use

tablet

Agiou Dimitriou 63
Alimos 17456
Greece
Greece

Genepharm S.A.

Desloratadine

Desloratadine/Genepharm

18 Km Marathon Avenue,

5 mg

15351 Pallini

5 mg

Film - coated

Oral use

tablet

Greece

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 41/131

Member State

Marketing Authorisation

(in EEA)

Holder

Greece

Genepharm S.A.

INN

Desloratadine

Invented name

Desloratadine/Genepharm

18 Km Marathon Avenue,

2,5 mg

15351 Pallini

Strength

2,5 mg

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

Greece
Greece

Genepharm S.A.

Desloratadine

Desloratadine/Genepharm

18 Km Marathon Avenue,

5 mg

15351 Pallini

5 mg

Orodispersible

Oral use

tablet

Greece
Greece

Generics Pharma Hellas Ltd

Donepezil

577a Vouliagmenis Avenue

hydrochloride

Donepezil/ Generics

5 mg

Orodispersible

Oral use

tablet

Argyroupoli
164-51 Athens
Greece
Greece

Generics Pharma Hellas Ltd

Donepezil

577a Vouliagmenis Avenue

hydrochloride

Donepezil/ Generics

10 mg

Orodispersible

Oral use

tablet

Argyroupoli
164-51 Athens
Greece
Greece

Generics Pharma Hellas Ltd

Esomeprazole

577a Vouliagmenis Avenue

magnesium

Esomeprazole/ Generics

40 mg

Prolonged -

Oral use

release capsule

Argyroupoli
164-51 Athens
Greece

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 42/131

Member State

Marketing Authorisation

(in EEA)

Holder

Greece

Sieger Pharma A.E.

INN

Desloratadine

Invented name

Desloratadine/Sieger

Strength

5 mg

Marathonos Avenue 106

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

Pikermi 19009
Greece
Greece

Sieger Pharma A.E.

Desloratadine

Desloratadine/Sieger

2,5 mg

Marathonos Avenue 106

Orodispersible

Oral use

tablet

Pikermi 19009
Greece
Greece

Sieger Pharma A.E.

Desloratadine

Desloratadine/Sieger

5 mg

Marathonos Avenue 106

Orodispersible

Oral use

tablet

Pikermi 19009
Greece
Hungary

Actavis Group PTC ehf.

Metformin

Gluforlyn XR 500 mg

Reykjavikurvegi 76-78

hydrochloride

retard tabletta

Desloratadine

Alvotadin 5 mg filmtabletta

500 mg

Prolonged -

Oral use

release tablet

220 Hafnarfjrdur
Iceland
Hungary

Alvogen IPCo S.ar.l.

5 mg

Rue Heienhaff 5

Film - coated

Oral use

tablet

L-1736 Senningerberg
Luxembourg
Hungary

Alvogen IPCo S.ar.l.


Rue Heienhaff 5

Desloratadine

Alvotadin 2.5 mg szjban


diszpergld tabletta

2,5 mg

Orodispersible

Oral use

tablet

L-1736 Senningerberg
Luxembourg

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 43/131

Member State

Marketing Authorisation

(in EEA)

Holder

Hungary

Alvogen IPCo S.ar.l.

INN

Desloratadine

Rue Heienhaff 5

Invented name

Alvotadin 5 mg szjban

Strength

5 mg

diszpergld tabletta

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

L-1736 Senningerberg
Luxembourg
Hungary

Generics (UK) Ltd

Esomeprazole

Station Close, Potters Bar

magnesium

Hertfordshire, EN6 1TL

Esomeprazol Mylan 20 mg

20 mg

gyomornedv-ellenll

Gastro - resistant

Oral use

capsule, hard

kemny kapszula

United Kingdom
Hungary

Generics (UK) Ltd

Esomeprazole

Station Close, Potters Bar

magnesium

Hertfordshire, EN6 1TL

Esomeprazol Mylan 40 mg

40 mg

gyomornedv-ellenll

Gastro - resistant

Oral use

capsule, hard

kemny kapszula

United Kingdom
Hungary

Glenmark Pharmaceuticals

Trimetazidine

Apstar 35 mg retard

s.r.o.

dihydrochloride

tabletta

Desloratadine

Inaller 5 mg filmtabletta

35 mg

Prolonged -

Oral use

release tablet

Hvzdova 1716/2b
14078 Praha 4
Czech Republic
Hungary

Goodwill Pharma Kft.

5 mg

H-6724 Szeged

Film - coated

Oral use

tablet

Cserzy Mihly u. 32.


Hungary
Hungary

Mylan SAS
117 alle des Parcs

Trimetazidine

Trimetazidine Mylan 35 mg
retard tabletta

35 mg

Prolonged -

Oral use

release tablet

69792 Saint-Priest Cedex


France

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 44/131

Member State

Marketing Authorisation

(in EEA)

Holder

Hungary

Sandoz Hungria Kft.

Trimetazidine

Trimetazidine Sandoz 35

H-1114 Budapest

dihydrochloride

mg retard tabletta

Desloratadine

Desloratadin Teva 2.5 mg

INN

Invented name

Strength

35 mg

Pharmaceutical

Route of

Form

administration

Prolonged -

Oral use

release tablet

Bartk Bla t 43-47.


Hungary
Hungary

Teva Gygyszergyr Zrt.


H-4042 Debrecen

szjban diszpergld

Pallagi t 13.

tabletta

2,5 mg

Orodispersible

Oral use

tablet

Hungary
Hungary

Teva Gygyszergyr Zrt.

Desloratadine

Desloratadin Teva 5 mg

H-4042 Debrecen

szjban diszpergld

Pallagi t 13.

tabletta

5 mg

Orodispersible

Oral use

tablet

Hungary
Iceland

ratiopharm GmbH

Desloratadine

Desloratadine ratiopharm

5 mg

Graf-Arco-Strasse 3

Orodispersible

Oral use

tablet

D-89079 Ulm
Germany
Ireland

Accord Healthcare Limited

Ropinirole

Ropinirole 0.25 mg Film-

Sage House, 319 Pinner Road

hydrochloride

coated Tablets

Accord Healthcare Limited

Ropinirole

Ropinirole 0.5 mg Film-

Sage House, 319 Pinner Road

hydrochloride

coated Tablets

0,25 mg

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
Ireland

0,5 mg

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 45/131

Member State

Marketing Authorisation

(in EEA)

Holder

Ireland

Accord Healthcare Limited

Ropinirole

Ropinirole 1 mg Film-

Sage House, 319 Pinner Road

hydrochloride

coated Tablets

Accord Healthcare Limited

Ropinirole

Ropinirole 2 mg Film-

Sage House, 319 Pinner Road

hydrochloride

coated Tablets

Accord Healthcare Limited

Ropinirole

Ropinirole 5 mg Film-

Sage House, 319 Pinner Road

hydrochloride

coated Tablets

Alendronic acid

Alendronic Acid Once

INN

Invented name

Strength

1 mg

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
Ireland

2 mg

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
Ireland

5 mg

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
Ireland

Accord Healthcare Limited


Sage House, 319 Pinner Road

70 mg

Tablet

Oral use

Oral use

Weekly 70 mg Tablets

North Harrow HA1 4HF


Middlesex
United Kingdom
Ireland

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/Hydrochlorothiaz

160

Film - coated

Planckstrasse 13

orothiazide

ide Fair-Med 160 mg/12.5

mg/12,5

tablet

mg film-coated tablets.

mg

DE-22765 Hamburg
Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Ireland

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Planckstrasse 13

orothiazide

INN

DE-22765 Hamburg

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Oral use

Valsartan/Hydrochlorothiaz

320

Film - coated
tablet

ide Fair-Med 320 mg/12.5

mg/12,5

mg film-coated tablets

mg

Valsartan/Hydrochlorothiaz

320 mg/25

Film - coated

ide Fair-Med 320 mg/25

mg

tablet

120 mg

Film - coated

Germany
Ireland

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Planckstrasse 13

orothiazide

DE-22765 Hamburg

Oral use

mg film-coated tablets

Germany
Ireland

Fannin (UK) Ltd

Fexofenadine

Fexofenadine 120 mg film-

42-46 Booth Drive

hydrochloride

coated tablets

Fannin (UK) Ltd

Fexofenadine

Fexofenadine 180 mg film-

42-46 Booth Drive

hydrochloride

coated tablets

Donepezil

Aripil Orotab 5mg

Oral use

tablet

Park Farm South


Wellingborough
Northamptonshire NN8 6GT
United Kingdom
Ireland

180 mg

Film - coated

Oral use

tablet

Park Farm South


Wellingborough
Northamptonshire NN8 6GT
United Kingdom
Ireland

McDermott Laboratories Ltd


t/a Gerard Laboratories

Orodispersible Tablet

5 mg

Orodispersible

Oral use

tablet

35/36 Baldoyle Industrial


Estate
Grange Road
Dublin 13
Ireland
GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 47/131

Member State

Marketing Authorisation

(in EEA)

Holder

Ireland

McDermott Laboratories Ltd

INN

Donepezil

t/a Gerard Laboratories

Invented name

Aripil Orotab 10mg

Strength

10 mg

Orodispersible Tablet

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

35/36 Baldoyle Industrial


Estate
Grange Road
Dublin 13
Ireland
Ireland

McDermott Laboratories Ltd

Esomeprazole

Esomeprazole Mylan 20 mg

t/a Gerard Laboratories

Gastro-resistant Capsules,

35/36 Baldoyle Industrial

hard

20 mg

Gastro - resistant

Oral use

capsule

Estate
Grange Road
Dublin 13
Ireland
Ireland

McDermott Laboratories Ltd

Esomeprazole

Esomeprazole Mylan 40 mg

t/a Gerard Laboratories

Gastro-resistant Capsules,

35/36 Baldoyle Industrial

hard

40 mg

Gastro - resistant

Oral use

capsule

Estate
Grange Road
Dublin 13
Ireland

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 48/131

Member State

Marketing Authorisation

(in EEA)

Holder

Ireland

McDermott Laboratories Ltd

INN

Candesartan

t/a Gerard Laboratories

Invented name

Candesartan Mylan 4mg

Pharmaceutical

Route of

Form

administration

4 mg

Tablet

Oral use

8 mg

Tablet

Oral use

16 mg

Tablet

Oral use

Strength

Tablets

35/36 Baldoyle Industrial


Estate
Grange Road
Dublin 13
Ireland
Ireland

McDermott Laboratories Ltd

Candesartan

t/a Gerard Laboratories

Candesartan Mylan 8 mg
Tablets

35/36 Baldoyle Industrial


Estate
Grange Road
Dublin 13
Ireland
Ireland

McDermott Laboratories Ltd


t/a Gerard Laboratories

Candesartan

Candesartan Mylan 16 mg
Tablets

35/36 Baldoyle Industrial


Estate
Grange Road
Dublin 13
Ireland

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Ireland

McDermott Laboratories Ltd

INN

Candesartan

t/a Gerard Laboratories

Invented name

Candesartan Mylan 32 mg

Pharmaceutical

Route of

Form

administration

32 mg

Tablet

Oral use

250 mg

Film - coated

Oral use

Strength

Tablets

35/36 Baldoyle Industrial


Estate
Grange Road
Dublin 13
Ireland
Ireland

Morningside Healthcare

Phenoxymethyl

Phenoxymethylpenicillin

Limited

penicillin

250mg Film-coated Tablets

Amlodipine besilate

Amlodipine Niche 5mg

tablet

115 Narborough Road


Leicester, LE3 0PA
United Kingdom
Ireland

Niche Generics Limited


1 The Cam Centre

5 mg

Tablet

Oral use

10 mg

Tablet

Oral use

150 mg

Film - coated

Oral use

tablets

Wilbury Way, Hitchin


Hertfordshire SG4 0TW
United Kingdom
Ireland

Niche Generics Limited

Amlodipine besilate

1 The Cam Centre

Amlodipine Niche 10mg


Tablets

Wilbury Way, Hitchin


Hertfordshire SG4 0TW
United Kingdom
Ireland

Niche Generics Limited


1 The Cam Centre

Irbesartan

Irbesartan Niche 150mg


film coated tablets

tablet

Wilbury Way, Hitchin


Hertfordshire SG4 0TW
United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Ireland

Niche Generics Limited

INN

Irbesartan

1 The Cam Centre

Invented name

Irbesartan Niche 300mg

Strength

300 mg

film coated tablets

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

Wilbury Way, Hitchin


Hertfordshire SG4 0TW
United Kingdom
Ireland

Wockhardt UK Limited

Clopidogrel

Clopidogrel 75mg film-

Ash Road North

hydrochloride

coated tablets

Metoclopramide

METOCLOPRAMIDE

75 mg

Film - coated

Oral use

tablet

Wrexham Industrial Estate


Wrexham LL13 9UF
United Kingdom
Italy

Accord Healthcare Italia S.r.l.


Largo Esterle, 4

10 mg

Tablet

Oral use

ACCORD

20052 Monza
Italy
Italy

Accord Healthcare Limited

Alendronic acid

ALENDRONATO AHCL

10 mg

Tablet

Oral use

Alendronic acid

ALENDRONATO AHCL

70 mg

Tablet

Oral use

Sage House, 319 Pinner Road


North Harrow HA1 4HF
Middlesex
United Kingdom
Italy

Accord Healthcare Limited


Sage House, 319 Pinner Road
North Harrow HA1 4HF
Middlesex
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Italy

Doc Generici SRL

INN

Desloratadine

Via Turati, 40

Invented name

DESLORATADINA DOC

Strength

5 mg

GENERICI

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

20121 Milano
Italy
Italy

Doc Generici SRL

Desloratadine

Via Turati, 40

DESLORATADINA DOC

2,5 mg

GENERICI

Orodispersible

Oral use

tablet

20121 Milano
Italy
Italy

Doc Generici SRL

Desloratadine

Via Turati, 40

DESLORATADINA DOC

5 mg

GENERICI

Orodispersible

Oral use

tablet

20121 Milano
Italy
Italy

Farmaceutici Caber S.P.A.

Valsartan

VALSOTEN

40 mg

Viale Citta' D'Europa, 681

Film - coated

Oral use

tablet

00144 Rome
Italy
Italy

Farmaceutici Caber S.P.A.

Valsartan

VALSOTEN

80 mg

Viale Citta' D'Europa, 681

Film - coated

Oral use

tablet

00144 Rome
Italy
Italy

Farmaceutici Caber S.P.A.

Valsartan

VALSOTEN

Viale Citta' D'Europa, 681

160 mg

Film - coated

Oral use

tablet

00144 Rome
Italy

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Italy

Farmaceutici Caber S.P.A.

INN

Valsartan

Invented name

VALSOTEN

Strength

320 mg

Viale Citta' D'Europa, 681

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

00144 Rome
Italy
Italy

Mylan S.P.A.

Esomeprazole

Via Vittor Pisani, 20

magnesium

ESOMEPRAZOLO MYLAN

20 mg

Gastro - resistant

Oral use

capsule, hard

20124 Milan
Italy
Italy

Mylan S.P.A.

Esomeprazole

Via Vittor Pisani, 20

magnesium

ESOMEPRAZOLO MYLAN

40 mg

Gastro - resistant

Oral use

capsule, hard

20124 Milan
Italy
Italy

Mylan S.P.A.

Rizatriptan

RIAZATRIPTAN MYLAN

Via Vittor Pisani, 20

benzoate

GENERICS

Mylan S.P.A.

Rizatriptan

RIAZATRIPTAN MYLAN

Via Vittor Pisani, 20

benzoate

GENERICS

Mylan S.P.A.

Donepezil

DONEPEZIL MYLAN

Via Vittor Pisani, 20

hydrochloride

GENERICS ITALIA

5 mg

Orodispersible

Oral use

tablet

20124 Milan
Italy
Italy

10 mg

Orodispersible

Oral use

tablet

20124 Milan
Italy
Italy

5 mg

Orodispersible

Oral use

tablet

20124 Milan
Italy

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Italy

Mylan S.P.A.

Donepezil

DONEPEZIL MYLAN

Via Vittor Pisani, 20

hydrochloride

GENERICS ITALIA

Repaglinide

REPAGLINIDE MYLAN

0,5 mg

Tablet

Oral use

Repaglinide

REPAGLINIDE MYLAN

1 mg

Tablet

Oral use

Repaglinide

REPAGLINIDE MYLAN

2 mg

Tablet

Oral use

Alendronic acid

Alendronato Pensa

70 mg

Tablet

Oral use

70 mg

Tablet

Oral use

INN

Invented name

Strength

10 mg

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

20124 Milan
Italy
Italy

Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Italy

Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Italy

Mylan S.P.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Italy

Pensa Pharma S.P.A.


Via Rossellini Ippolito, 12

70 mg compresse

20124 Milan
Italy
Italy

Ranbaxy Italia S.P.A.


Piazza Filippo Meda, 4, 3

Alendronic acid

ALENDRONATO RANBAXY
ITALIA

20121 - Milano
Italy

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Latvia

Sandoz Pharmaceuticals d.d.

Trimetazidine

Verovskova 57

dihydrochloride

INN

Invented name

Zidmetin

Strength

35 mg

Pharmaceutical

Route of

Form

administration

Modified - release

Oral use

tablet

Ljubljana SI-1000
Slovenia
Lithuania

Accord Healthcare Limited

Alendronic acid

Alendronic acid Accord

70 mg

Tablet

Oral use

Ropinirole

Ropinirole Lambada

0,5 mg

Film - coated

Oral use

Sage House, 319 Pinner Road


North Harrow HA1 4HF
Middlesex
United Kingdom
Lithuania

Lambda Therapeutic Limited


Sage House

tablet

319 Pinner Road, North


Harrow
Middlesex HA1 4HF
United Kingdom
Lithuania

Lambda Therapeutic Limited

Ropinirole

Ropinirole Lambada

1 mg

Sage House

Film - coated

Oral use

tablet

319 Pinner Road, North


Harrow
Middlesex HA1 4HF
United Kingdom
Lithuania

Lambda Therapeutic Limited

Ropinirole

Ropinirole Lambada

Sage House

2 mg

Film - coated

Oral use

tablet

319 Pinner Road, North


Harrow
Middlesex HA1 4HF
United Kingdom
GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Lithuania

Lambda Therapeutic Limited

INN

Ropinirole

Invented name

Ropinirole Lambada

Strength

5 mg

Sage House

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

319 Pinner Road, North


Harrow
Middlesex HA1 4HF
United Kingdom
Lithuania

Torrent Pharma GmbH

Irbesartan

Irbesartanas Torrent

75 mg

Sdwestpark 50

Film - coated

Oral use

tablet

90449 Nrnberg
Germany
Lithuania

Torrent Pharma GmbH

Irbesartan

Irbesartanas Torrent

150 mg

Sdwestpark 50

Film - coated

Oral use

tablet

90449 Nrnberg
Germany
Lithuania

Torrent Pharma GmbH

Irbesartan

Irbesartanas Torrent

300 mg

Sdwestpark 50

Film - coated

Oral use

tablet

90449 Nrnberg
Germany
Lithuania

Torrent Pharma GmbH

Irbesartan/hydroch

Irbesartanas/Hidrochlorotia

150

Film - coated

Sdwestpark 50

lorothiazide

zidas Torrent

mg/12,5

tablet

90449 Nrnberg

Oral use

mg

Germany
Lithuania

Torrent Pharma GmbH

Irbesartan/hydroch

Irbesartanas/Hidrochlorotia

300

Film - coated

Sdwestpark 50

lorothiazide

zidas Torrent

mg/12,5

tablet

90449 Nrnberg

Oral use

mg

Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Lithuania

Torrent Pharma GmbH

Irbesartan/hydroch

Irbesartanas/Hidrochlorotia

Sdwestpark 50

lorothiazide

Repaglinide

INN

Pharmaceutical

Route of

Form

administration

300 mg/25

Film - coated

Oral use

zidas Torrent

mg

tablet

Repaglinide Mylan Pharma

0,5 mg

Tablet

Oral use

1 mg

Tablet

Oral use

2 mg

Tablet

Oral use

20 mg

Gastro - resistant

Oral use

Invented name

Strength

90449 Nrnberg
Germany
Luxembourg

Mylan bvba/sprl
Terhulpsesteenweg 6A

0,5 mg tabletten

1560 Hoeilaart
Belgium
Luxembourg

Mylan bvba/sprl

Repaglinide

Terhulpsesteenweg 6A

Repaglinide Mylan Pharma


1 mg tabletten

1560 Hoeilaart
Belgium
Luxembourg

Mylan bvba/sprl

Repaglinide

Terhulpsesteenweg 6A

Repaglinide Mylan Pharma


2 mg tabletten

1560 Hoeilaart
Belgium
Luxembourg

Mylan bvba/sprl

Esomeprazole

Esomeprazole Mylan

Terhulpsesteenweg 6A

capsule, hard

1560 Hoeilaart
Belgium
Luxembourg

Mylan bvba/sprl

Esomeprazole

Esomeprazole Mylan

Terhulpsesteenweg 6A

40 mg

Gastro - resistant

Oral use

capsule, hard

1560 Hoeilaart
Belgium

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Malta

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/hydrochlorthiazid

Planckstrasse 13

orothiazide

"Fair-Med" Coated tablets

INN

Invented name

DE-22765 Hamburg

Pharmaceutical

Route of

Form

administration

160

Film - coated

Oral use

mg/12,5

tablet

Strength

mg

Germany
Malta

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/hydrochlorthiazid

320

Film - coated

Planckstrasse 13

orothiazide

"Fair-Med" Coated tablets

mg/12,5

tablet

DE-22765 Hamburg

Oral use

mg

Germany
Malta

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/hydrochlorthiazid

320 mg/25

Film - coated

Planckstrasse 13

orothiazide

"Fair-Med" Coated tablets

mg

tablet

Ciprofloxacin

Ciprofloxacin Fair-Med

250 mg

Film - coated

Oral use

DE-22765 Hamburg
Germany
Malta

Fair-Med Healthcare GmbH


Planckstrasse 13

Coated Tablets

Oral use

tablet

DE-22765 Hamburg
Germany
Malta

Fair-Med Healthcare GmbH

Ciprofloxacin

Planckstrasse 13

Ciprofloxacin Fair-Med

500 mg

Coated Tablets

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany
Malta

Fair-Med Healthcare GmbH


Planckstrasse 13

irbesartan

Irbesartan Fairmed 75mg


Film-coated Tablets

75 mg

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Malta

Fair-Med Healthcare GmbH

INN

irbesartan

Planckstrasse 13

Invented name

Irbesartan Fairmed 150mg

Strength

150 mg

Film-coated Tablets

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany
Malta

Fair-Med Healthcare GmbH

irbesartan

Planckstrasse 13

Irbesartan Fairmed 300mg

300 mg

Film-coated Tablets

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany
Malta

Malta

Malta

Fair-Med Healthcare GmbH

Irbesartan/hydroch

Irbesartan/Hydrochlorothia

150

Film - coated

Planckstrasse 13

lorothiazide

tablet

zide Fairmed

mg/12,5

DE-22765 Hamburg

150mg/12.5mg film-coated

mg

Germany

tablets

Fair-Med Healthcare GmbH

Irbesartan/hydroch

Irbesartan/Hydrochlorothia

300

Film - coated

Planckstrasse 13

lorothiazide

zide Fairmed

mg/12,5

tablet

DE-22765 Hamburg

300mg/12.5mg film-coated

mg

Germany

tablets

Fair-Med Healthcare GmbH

Irbesartan/hydroch

Irbesartan/Hydrochlorothia

300 mg/25

Film - coated

Planckstrasse 13

lorothiazide

zide Fairmed 300mg/25mg

mg

tablet

37,5 mg

Prolonged -

DE-22765 Hamburg

Oral use

Oral use

Oral use

film-coated tablets

Germany
Malta

Fair-Med Healthcare GmbH

Venlafaxine

Venlafaxine Fair-Med

Planckstrasse 13

release capsule,

DE-22765 Hamburg

hard

Oral use

Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Malta

Fair-Med Healthcare GmbH

INN

Venlafaxine

Invented name

Venlafaxine Fair-Med

Strength

75 mg

Pharmaceutical

Route of

Form

administration

Prolonged -

Oral use

Planckstrasse 13

release capsule,

DE-22765 Hamburg

hard

Germany
Malta

Fair-Med Healthcare GmbH

Venlafaxine

Venlafaxine Fair-Med

150 mg

Prolonged -

Planckstrasse 13

release capsule,

DE-22765 Hamburg

hard

Oral use

Germany
Malta

Wockhardt UK Limited

Clopidogrel

Ash Road North

Clopidogrel 75mg Film-

75 mg

coated Tablets

Film - coated

Oral use

tablet

Wrexham Industrial Estate


Wrexham LL13 9UF
United Kingdom
Malta

Wockhardt UK Limited

Clopidogrel

Ash Road North

Clopidogrel 75mg Coated

75 mg

Tablets

Film - coated

Oral use

tablet

Wrexham Industrial Estate


Wrexham LL13 9UF
United Kingdom
Norway

Bluefish Pharmaceuticals AB

Fluconazole

Fluconazol Bluefish

50 mg

Capsule, hard

Oral use

Fluconazole

Fluconazol Bluefish

150 mg

Capsule, hard

Oral use

Torsgatan 11
SE-11123 Stockholm
Sweden
Norway

Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Norway

Bluefish Pharmaceuticals AB

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Fluconazole

Fluconazol Bluefish

200 mg

Capsule, hard

Oral use

Esomeprazole

Esomeprazol Mylan

20 mg

Gastro - resistant

Oral use

Torsgatan 11
SE-11123 Stockholm
Sweden
Norway

Mylan AB
PO Box 230 33

capsule, hard

SE-104 35 Stockholm
Sweden
Norway

Mylan AB

Esomeprazole

Esomeprazol Mylan

40 mg

PO Box 230 33

Gastro - resistant

Oral use

capsule, hard

SE-104 35 Stockholm
Sweden
Norway

Mylan AB

Eletriptan

Eletriptan Mylan

20 mg

PO Box 230 33

Film - coated

Oral use

tablet

SE-104 35 Stockholm
Sweden
Norway

Mylan AB

Eletriptan

Eletriptan Mylan

40 mg

PO Box 230 33

Film - coated

Oral use

tablet

SE-104 35 Stockholm
Sweden
Norway

Mylan AB

Candesartan

PO Box 230 33

cilexetil

Kandrozid

4 mg

tablet

Oral use

SE-104 35 Stockholm
Sweden

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Norway

Mylan AB

Candesartan

PO Box 230 33

cilexetil

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Kandrozid

8 mg

tablet

Oral use

Kandrozid

16 mg

tablet

Oral use

Kandrozid

32 mg

tablet

Oral use

Mylcande

8 mg

tablet

Oral use

Mylcande

16 mg

tablet

Oral use

Mylcande

32 mg

tablet

Oral use

SE-104 35 Stockholm
Sweden
Norway

Mylan AB

Candesartan

PO Box 230 33

cilexetil

SE-104 35 Stockholm
Sweden
Norway

Mylan AB

Candesartan

PO Box 230 33

cilexetil

SE-104 35 Stockholm
Sweden
Norway

Mylan AB

Candesartan

PO Box 230 33

cilexetil

SE-104 35 Stockholm
Sweden
Norway

Mylan AB

Candesartan

PO Box 230 33

cilexetil

SE-104 35 Stockholm
Sweden
Norway

Mylan AB

Candesartan

PO Box 230 33

cilexetil

SE-104 35 Stockholm
Sweden

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Norway

Mylan AB

INN

Rizatriptan

PO Box 230 33

Invented name

RIZATRIPTAN MYLAN 10

Strength

10 mg

mg, orodispersible tablet

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

SE-104 35 Stockholm
Sweden
Norway

ratiopharm GmbH

Desloratadine

Desloratadin Ratiopharm

2,5 mg

Graf-Arco-Strasse 3

Orodispersible

Oral use

tablet

D-89079 Ulm
Germany
Norway

ratiopharm GmbH

Desloratadine

Desloratadin Ratiopharm

5 mg

Graf-Arco-Strasse 3

Orodispersible

Oral use

tablet

D-89079 Ulm
Germany
Poland

Abbott Laboratories Poland

Escitalopram

Savandra

5 mg

Sp. z o.o.

Film - coated

Oral use

tablet

ul. Postpu 21B


02-676 Warszawa
Poland
Poland

Abbott Laboratories Poland

Escitalopram

Savandra

Sp. z o.o.

10 mg

Film - coated

Oral use

tablet

ul. Postpu 21B


02-676 Warszawa
Poland

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Poland

Abbott Laboratories Poland

INN

Escitalopram

Invented name

Savandra

Strength

15 mg

Sp. z o.o.

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

ul. Postpu 21B


02-676 Warszawa
Poland
Poland

Abbott Laboratories Poland

Escitalopram

Savandra

20 mg

Sp. z o.o.

Film - coated

Oral use

tablet

ul. Postpu 21B


02-676 Warszawa
Poland
Poland

Actavis Group PTC ehf.

Metformin

Metformin SR Actavis

500 mg

Reykjavikurvegi 76-78

Film - coated

Oral use

tablet

220 Hafnarfjrdur
Iceland
Poland

Actavis Group PTC ehf.

Metformin

Metformin SR Actavis

750 mg

Reykjavikurvegi 76-78

Film - coated

Oral use

tablet

220 Hafnarfjrdur
Iceland
Poland

Adamed Sp. z o.o.

Desloratadine

Desada

5 mg

Piekw 149

Orodispersible

Oral use

tablet

05-152 Czosnw k. Warszawy


Poland
Poland

Adamed Sp. z o.o.

Desloratadine

Hitaxa Fast

Piekw 149

2,5 mg

Orodispersible

Oral use

tablet

05-152 Czosnw k. Warszawy


Poland

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Poland

Adamed Sp. z o.o.

INN

Desloratadine

Invented name

Hitaxa

Strength

2,5 mg

Piekw 149

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

05-152 Czosnw k. Warszawy


Poland
Poland

Adamed Sp. z o.o.

Desloratadine

Hitaxa

5 mg

Piekw 149

Orodispersible

Oral use

tablet

05-152 Czosnw k. Warszawy


Poland
Poland

Aflofarm Farmacja Polska Sp.

Desloratadine

Teslor

5 mg

z o.o.

Film - coated

Oral use

tablet

ul. Partyzancka 133/151


95-200 Pabianice
Poland
Poland

Aflofarm Farmacja Polska Sp.

Desloratadine

Teslor fast

5 mg

z o.o.

Orodispersible

Oral use

tablet

ul. Partyzancka 133/151


95-200 Pabianice
Poland
Poland

Aflofarm Farmacja Polska Sp.

Desloratadine

Teslor fast junior

z o.o.

2,5 mg

Orodispersible

Oral use

tablet

ul. Partyzancka 133/151


95-200 Pabianice
Poland

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Poland

Apotex Europe B.V.

INN

Trimetazidine

Invented name

ApoTrimet PR

Strength

35 mg

Darwinweg 20

Pharmaceutical

Route of

Form

administration

Prolonged -

Oral use

release tablet

NL 2333 CR Leiden
Netherlands
Poland

Bio-Profil Polska Sp. z o.o.

Desloratadine

Desloratadine Peseri

5 mg

Trakt Lubelski 135

Film - coated

Oral use

tablet

04-790 Warszawa
Poland
Poland

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Planckstrasse 13

orothiazide

Valsartan HCT Fair-Med

DE-22765 Hamburg

320

Film - coated

mg/12,5

tablet

Oral use

mg

Germany
Poland

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Planckstrasse 13

orothiazide

Valsartan HCT Fair-Med

320 mg/25

Film - coated

mg

tablet

250 mg

Film - coated

Oral use

DE-22765 Hamburg
Germany
Poland

Fair-Med Healthcare GmbH

Ciprofloxacin

Ciprofloxacin Fair-Med

Planckstrasse 13

Oral use

tablet

DE-22765 Hamburg
Germany
Poland

Fair-Med Healthcare GmbH

Ciprofloxacin

Ciprofloxacin Fair-Med

Planckstrasse 13

500 mg

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Poland

Fair-Med Healthcare GmbH

INN

Irbesartan

Invented name

Irbesartan Fair-Med

Strength

75 mg

Planckstrasse 13

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany
Poland

Fair-Med Healthcare GmbH

Irbesartan

Irbesartan Fair-Med

150 mg

Planckstrasse 13

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany
Poland

Fair-Med Healthcare GmbH

Irbesartan

Irbesartan Fair-Med

300 mg

Planckstrasse 13

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany
Poland

Fair-Med Healthcare GmbH

Irbesartan/hydroch

Planckstrasse 13

lorothiazide

Irbesartan HCT Fair-Med

DE-22765 Hamburg

150

Film - coated

mg/12,5

tablet

Oral use

mg

Germany
Poland

Fair-Med Healthcare GmbH

Irbesartan/hydroch

Planckstrasse 13

lorothiazide

Irbesartan HCT Fair-Med

DE-22765 Hamburg

300

Film - coated

mg/12,5

tablet

Oral use

mg

Germany
Poland

Fair-Med Healthcare GmbH

Irbesartan/hydroch

Planckstrasse 13

lorothiazide

Irbesartan HCT Fair-Med

300 mg/25

Film - coated

mg

tablet

Oral use

DE-22765 Hamburg
Germany

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Member State

Marketing Authorisation

(in EEA)

Holder

Poland

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Planckstrasse 13

orothiazide

INN

Invented name

Valsartan HCT Fair-Med

DE-22765 Hamburg

Pharmaceutical

Route of

Form

administration

160

Film - coated

Oral use

mg/12,5

tablet

Strength

mg

Germany
Poland

Fair-Med Healthcare GmbH

Venlafaxine

VENLAFAXINE FAIR-MED

37,5 mg

Prolonged -

Planckstrasse 13

release capsule,

DE-22765 Hamburg

hard

Oral use

Germany
Poland

Fair-Med Healthcare GmbH

Venlafaxine

VENLAFAXINE FAIR-MED

75 mg

Prolonged -

Planckstrasse 13

release capsule,

DE-22765 Hamburg

hard

Oral use

Germany
Poland

Fair-Med Healthcare GmbH

Venlafaxine

VENLAFAXINE FAIR-MED

150 mg

Prolonged -

Planckstrasse 13

release capsule,

DE-22765 Hamburg

hard

Oral use

Germany
Poland

Generics (UK) Ltd

Candesartan

Station Close, Potters Bar

cilexetil

Kangen

8 mg

Tablet

Oral use

Kangen

16 mg

Tablet

Oral use

Hertfordshire, EN6 1TL


United Kingdom
Poland

Generics (UK) Ltd

Candesartan

Station Close, Potters Bar

cilexetil

Hertfordshire, EN6 1TL


United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

Poland

Labormed-Pharma, SA

INN

Desloratadine

Invented name

Desloratadine Labormed

Strength

2,5 mg

Theodor Pallady, 44B

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

032266 Bucharest
Romania
Poland

Labormed-Pharma, SA

Desloratadine

Desloratadine Labormed

5 mg

Theodor Pallady, 44B

Orodispersible

Oral use

tablet

032266 Bucharest
Romania
Poland

Medicplast Polska Sp. z o.o

Desloratadine

Desalergo

5 mg

ul. Wlczyska 232

Film - coated

Oral use

tablet

01-919 Warszawa
Poland
Poland

Medicplast Polska Sp. z o.o

Desloratadine

Desalergo

2,5 mg

ul. Wlczyska 232

Orodispersible

Oral use

tablet

01-919 Warszawa
Poland
Poland

Medicplast Polska Sp. z o.o

Desloratadine

Desalergo

5 mg

ul. Wlczyska 232

Orodispersible

Oral use

tablet

01-919 Warszawa
Poland
Poland

Orion Corporation

Valsartan

Valsartan Orion

Orion Pharma

40 mg

Film - coated

Oral use

tablet

PO BOX 65
02101 Espoo
Finland

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Member State

Marketing Authorisation

(in EEA)

Holder

Poland

Orion Corporation

INN

Valsartan

Invented name

Valsartan Orion

Strength

80 mg

Orion Pharma

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

PO BOX 65
02101 Espoo
Finland
Poland

Orion Corporation

Valsartan

Valsartan Orion

160 mg

Orion Pharma

Film - coated

Oral use

tablet

PO BOX 65
02101 Espoo
Finland
Poland

Orion Corporation

Valsartan

Valsartan Orion

320 mg

Orion Pharma

Film - coated

Oral use

tablet

PO BOX 65
02101 Espoo
Finland
Poland

Peseri Trading Limited

Desloratadine

Desloratadine Peseri

2,5 mg

20 Queen Frederica Street

Orodispersible

Oral use

tablet

El-Greco House, office 301


1066 Nicosia
Cyprus
Poland

Peseri Trading Limited

Desloratadine

Desloratadine Peseri

20 Queen Frederica Street

5 mg

Orodispersible

Oral use

tablet

El-Greco House, office 301


1066 Nicosia
Cyprus

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Member State

Marketing Authorisation

(in EEA)

Holder

Poland

Ranbaxy (Poland) Sp. z o.o.

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Alendronic acid

Alendran 70

70 mg

Tablet

Oral use

Trimetazidine

Dimesar

35 mg

Prolonged -

Oral use

Kubickiego 11
02-954 Warszawa
Poland
Poland

Sandoz GmbH
Biochemiestrasse 10

release tablet

A-6250 Kundl
Austria
Poland

S-Lab Sp. z o.o.

Desloratadine

Suprodeslon

5 mg

ul. Kieczowska 2

Film - coated

Oral use

tablet

55-095 Mirkw
Poland
Poland

S-Lab Sp. z o.o.

Desloratadine

Suprodeslon

2,5 mg

ul. Kieczowska 2

Orodispersible

Oral use

tablet

55-095 Mirkw
Poland
Poland

S-Lab Sp. z o.o.

Desloratadine

Suprodeslon

5 mg

ul. Kieczowska 2

Orodispersible

Oral use

tablet

55-095 Mirkw
Poland
Poland

SymPhar Sp. z o.o.

Desloratadine

Symdes

ul. Woska 1

5 mg

Film - coated

Oral use

tablet

00-777 Warszawa
Poland

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Member State

Marketing Authorisation

(in EEA)

Holder

Poland

Tactica Pharmaceuticals sp. z

INN

Desloratadine

Invented name

Goldesin

Strength

5 mg

o.o.

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

ul. Bankowa 4
44-100 Gliwice
Poland
Poland

US Pharmacia Sp. z o.o.

Desloratadine

Aleric Deslo

5 mg

ul.Zibicka 40

Film - coated

Oral use

tablet

50-507 Wrocaw
Poland
Poland

US Pharmacia Sp. z o.o.

Desloratadine

Aleric Deslo

2,5 mg

ul.Zibicka 40

Orodispersible

Oral use

tablet

50-507 Wrocaw
Poland
Poland

US Pharmacia Sp. z o.o.

Desloratadine

Aleric Deslo Active

5 mg

ul.Zibicka 40

Orodispersible

Oral use

tablet

50-507 Wrocaw
Poland
Poland

Wockhardt UK Limited

Clopidogrel

Clopidogrel Wockhardt

Ash Road North

75 mg

Film - coated

Oral use

tablet

Wrexham Industrial Estate


Wrexham LL13 9UF
United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Accord Healthcare Limited

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Alendronic acid

cido alendrnico Accord

70 mg

tablet

Oral use

Cefpodoxime

Cefpodoxima Alkaloid

200 mg

Tablet

Oral use

Brown & Burk UK, Ltd.

Tramadol/paraceta

Tramadol + Paracetamol

37,5

Film - coated

Oral use

5, Marryat Close

mol

Brown

mg/325 mg

tablet

Trimetazidine

Trimetazidina Brown

35 mg

Sage House, 319 Pinner Road


North Harrow HA1 4HF
Middlesex
United Kingdom
Portugal

Alkaloid - INT d.o.o.


landrova 4
1231 Ljubljana - rnue
Slovenia

Portugal

Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal

Brown & Burk UK, Ltd.


5, Marryat Close

Modified - release

Oral use

tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal

Brown & Burk UK, Ltd.

Escitalopram

Escitalopram Brown

5, Marryat Close

10 mg

Film - coated

Oral use

tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Brown & Burk UK, Ltd.

INN

Escitalopram

Invented name

Escitalopram Brown

Strength

15 mg

5, Marryat Close

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal

Brown & Burk UK, Ltd.

Escitalopram

Escitalopram Brown

5 mg

5, Marryat Close

Film - coated

Oral use

tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal

Brown & Burk UK, Ltd.

Escitalopram

Escitalopram Brown

20 mg

5, Marryat Close

Film - coated

Oral use

tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal

Brown & Burk UK, Ltd.

Ebastine

Ebastina Brown

10 mg

5, Marryat Close

Film - coated

Oral use

tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom
Portugal

Brown & Burk UK, Ltd.

Ebastine

Ebastina Brown

5, Marryat Close

20 mg

Film - coated

Oral use

tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Daquimed - Comrcio de

INN

Quetiapine

Invented name

Quetiapina Daquimed

Strength

25 mg

Produtos Farmacuticos, S.A.

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

Av. Associao Comercial e


Industrial de Gondomar, 330
- Zona Industrial da
Portelinha
4510-688 Fnzeres
Portugal
Portugal

Daquimed - Comrcio de

Quetiapine

Quetiapina Daquimed

100 mg

Produtos Farmacuticos, S.A.

Film - coated

Oral use

tablet

Av. Associao Comercial e


Industrial de Gondomar, 330
- Zona Industrial da
Portelinha
4510-688 Fnzeres
Portugal
Portugal

Daquimed - Comrcio de

Quetiapine

Quetiapina Daquimed

Produtos Farmacuticos, S.A.

150 mg

Film - coated

Oral use

tablet

Av. Associao Comercial e


Industrial de Gondomar, 330
- Zona Industrial da
Portelinha
4510-688 Fnzeres
Portugal

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Daquimed - Comrcio de

INN

Quetiapine

Invented name

Quetiapina Daquimed

Strength

200 mg

Produtos Farmacuticos, S.A.

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

Av. Associao Comercial e


Industrial de Gondomar, 330
- Zona Industrial da
Portelinha
4510-688 Fnzeres
Portugal
Portugal

Daquimed - Comrcio de

Quetiapine

Quetiapina Daquimed

300 mg

Produtos Farmacuticos, S.A.

Film - coated

Oral use

tablet

Av. Associao Comercial e


Industrial de Gondomar, 330
- Zona Industrial da
Portelinha
4510-688 Fnzeres
Portugal
Portugal

Generis Farmacutica, S. A.

Levodopa/carbidop

Levodopa + Carbidopa +

50 mg/12,5

Film - coated

Rua Joo de Deus, 19

a/entacapone

Entacapona Generis

mg/200 mg

tablet

Generis Farmacutica, S. A.

Levodopa/carbidop

Levodopa + Carbidopa +

75

Film - coated

Rua Joo de Deus, 19

a/entacapone

Entacapona Generis

mg/18,75

tablet

Oral use

2700-487 Amadora
Portugal
Portugal

2700-487 Amadora

Oral use

mg/200 mg

Portugal

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Member State

Marketing Authorisation

Pharmaceutical

Route of

(in EEA)

Holder

Form

administration

Portugal

Generis Farmacutica, S. A.

Levodopa/carbidop

Levodopa + Carbidopa +

100 mg/25

Film - coated

Oral use

Rua Joo de Deus, 19

a/entacapone

Entacapona Generis

mg/200 mg

tablet

Generis Farmacutica, S. A.

Levodopa/carbidop

Levodopa + Carbidopa +

125

Film - coated

Rua Joo de Deus, 19

a/entacapone

Entacapona Generis

mg/31,250

tablet

INN

Invented name

Strength

2700-487 Amadora
Portugal
Portugal

2700-487 Amadora

Oral use

mg/200 mg

Portugal
Portugal

Generis Farmacutica, S. A.

Levodopa/carbidop

Levodopa + Carbidopa +

150

Film - coated

Rua Joo de Deus, 19

a/entacapone

Entacapona Generis

mg/37,5

tablet

2700-487 Amadora

Oral use

mg/200 mg

Portugal
Portugal

Generis Farmacutica, S. A.

Levodopa/carbidop

Levodopa + Carbidopa +

175

Film - coated

Rua Joo de Deus, 19

a/entacapone

Entacapona Generis

mg/43,75

tablet

2700-487 Amadora

Oral use

mg/200 mg

Portugal
Portugal

Generis Farmacutica, S. A.

Levodopa/carbidop

Levodopa + Carbidopa +

Rua Joo de Deus, 19

a/entacapone

Entacapona Generis

mg/200 mg

200 mg/50

Film - coated
tablet

Entacapone

Entacapona Generis

200 mg

Film - coated

Oral use

2700-487 Amadora
Portugal
Portugal

Generis Farmacutica, S. A.
Rua Joo de Deus, 19

Oral use

tablet

2700-487 Amadora
Portugal

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Labesfal, Genricos, S.A.

INN

Desloratadine

Invented name

Desloratadina Labesfal OD

Strength

2,5 mg

Av. Dr. Afonso Costa, n 1370

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

3465-051 Campo de Besteiros


Portugal
Portugal

Labesfal, Genricos, S.A.

Desloratadine

Desloratadina Labesfal OD

5 mg

Av. Dr. Afonso Costa, n 1370

Orodispersible

Oral use

tablet

3465-051 Campo de Besteiros


Portugal
Portugal

Labesfal, Genricos, S.A.

Alendronic acid

cido alendrnico Labesfal

70 mg

tablet

Oral use

Donepezil

Donepezilo Anova

5 mg

Orodispersible

Oral use

Av. Dr. Afonso Costa, n 1370


3465-051 Campo de Besteiros
Portugal
Portugal

Laboratrios Anova - Produtos


Farmacuticos, Lda.

tablet

Rua Doutor Antnio Loureiro


Borges
Edficio Arquiparque 1, R/C
Esq
1499-016 Algs
Portugal

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Laboratrios Anova - Produtos

INN

Donepezil

Invented name

Donepezilo Anova

Strength

10 mg

Farmacuticos, Lda.

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

Rua Doutor Antnio Loureiro


Borges
Edficio Arquiparque 1, R/C
Esq
1499-016 Algs
Portugal
Portugal

Laboratrios Anova - Produtos

Esomeprazole

Esomeprazol Anova

20 mg

Farmacuticos, Lda.

Gastro - resistant

Oral use

capsule, hard

Rua Doutor Antnio Loureiro


Borges
Edficio Arquiparque 1, R/C
Esq
1499-016 Algs
Portugal
Portugal

Laboratrios Anova - Produtos

Esomeprazole

Esomeprazol Anova

Farmacuticos, Lda.

40 mg

Gastro - resistant

Oral use

capsule, hard

Rua Doutor Antnio Loureiro


Borges
Edficio Arquiparque 1, R/C
Esq
1499-016 Algs
Portugal

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Laboratrios Azevedos -

INN

Venlafaxine

Invented name

Venlafaxina Azevedos

Strength

37,5 mg

Pharmaceutical

Route of

Form

administration

Prolonged -

Oral use

Indstria Farmacutica, S.A.

release capsule,

Edifcios Azevedos - Estrada

hard

Nacional 117-2, Alfragide


2614-504 Amadora
Portugal
Portugal

Laboratrios Azevedos -

Venlafaxine

Venlafaxina Azevedos

75 mg

Prolonged -

Indstria Farmacutica, S.A.

release capsule,

Edifcios Azevedos - Estrada

hard

Oral use

Nacional 117-2, Alfragide


2614-504 Amadora
Portugal
Portugal

Laboratrios Azevedos -

Venlafaxine

Venlafaxina Azevedos

150 mg

Prolonged -

Indstria Farmacutica, S.A.

release capsule,

Edifcios Azevedos - Estrada

hard

Oral use

Nacional 117-2, Alfragide


2614-504 Amadora
Portugal
Portugal

Laboratrios Basi - Indstria

Fluconazole

Fluconazol Basi

50 mg

Capsule

Oral use

Farmacutica, S.A
Parque Industrial Manuel
Loureno Ferreira, Lote 15
3450-232 Mortgua
Portugal

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Laboratrios Basi - Indstria

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Fluconazole

Fluconazol Basi

150 mg

Capsule

Oral use

Fluconazole

Fluconazol Basi

200 mg

Capsule

Oral use

Desloratadine

Desloratadina Labormed

5 mg

Orodispersible

Oral use

Farmacutica, S.A
Parque Industrial Manuel
Loureno Ferreira, Lote 15
3450-232 Mortgua
Portugal
Portugal

Laboratrios Basi - Indstria


Farmacutica, S.A
Parque Industrial Manuel
Loureno Ferreira, Lote 15
3450-232 Mortgua
Portugal

Portugal

Labormed-Pharma, SA
Theodor Pallady, 44B

tablet

032266 Bucharest
Romania
Portugal

Labormed-Pharma, SA

Desloratadine

Desloratadina Labormed

2,5 mg

Theodor Pallady, 44B

Orodispersible

Oral use

tablet

032266 Bucharest
Romania
Portugal

Lupin (Europe) Limited

Cefpodoxime

Cefpodoxima Lupin

Victoria Court, Bexton Road

200 mg

Film - coated

Oral use

tablet

Knutsford, Cheshire WA16


0PF
United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Mylan, Lda.

INN

Esomeprazole

Invented name

Esomeprazol Mylan

Strength

20 mg

Parque Expo, Edifcio Atlantis,

Pharmaceutical

Route of

Form

administration

Gastro - resistant

Oral use

capsule, hard

Avenida D. Joo II, Lote


1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal

Mylan, Lda.

Esomeprazole

Esomeprazol Mylan

40 mg

Parque Expo, Edifcio Atlantis,

Gastro - resistant

Oral use

capsule, hard

Avenida D. Joo II, Lote


1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal

Mylan, Lda.

Atorvastatin

Atorvastatina Anova

10 mg

Parque Expo, Edifcio Atlantis,

Film - coated

Oral use

tablet

Avenida D. Joo II, Lote


1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal

Mylan, Lda.

Atorvastatin

Atorvastatina Anova

Parque Expo, Edifcio Atlantis,

20 mg

Film - coated

Oral use

tablet

Avenida D. Joo II, Lote


1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Mylan, Lda.

INN

Atorvastatin

Invented name

Atorvastatina Anova

Strength

40 mg

Parque Expo, Edifcio Atlantis,

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

Avenida D. Joo II, Lote


1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal

Mylan, Lda.

Atorvastatin

Atorvastatina Anova

80 mg

Parque Expo, Edifcio Atlantis,

Film - coated

Oral use

tablet

Avenida D. Joo II, Lote


1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal

Mylan, Lda.

Donepezil

Donepezilo Mylan

5 mg

Parque Expo, Edifcio Atlantis,

Orodispersible

Oral use

tablet

Avenida D. Joo II, Lote


1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal

Mylan, Lda.

Donepezil

Donepezilo Mylan

Parque Expo, Edifcio Atlantis,

10 mg

Orodispersible

Oral use

tablet

Avenida D. Joo II, Lote


1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Mylan, Lda.

INN

Trimetazidine

Invented name

Trimetazidina Mylan

Strength

35 mg

Parque Expo, Edifcio Atlantis,

Pharmaceutical

Route of

Form

administration

Modified - release

Oral use

tablet

Avenida D. Joo II, Lote


1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal

Mylan, Lda.

Candesartan

Candesartan Mylan

4 mg

Tablet

Oral use

Candesartan

Candesartan Mylan

8 mg

Tablet

Oral use

Candesartan

Candesartan Mylan

16 mg

Tablet

Oral use

Parque Expo, Edifcio Atlantis,


Avenida D. Joo II, Lote
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal

Mylan, Lda.
Parque Expo, Edifcio Atlantis,
Avenida D. Joo II, Lote
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal

Portugal

Mylan, Lda.
Parque Expo, Edifcio Atlantis,
Avenida D. Joo II, Lote
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Mylan, Lda.

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Candesartan

Candesartan Mylan

32 mg

Tablet

Oral use

Desloratadine

Desloratadina Peseri

5 mg

Film - coated

Oral use

Parque Expo, Edifcio Atlantis,


Avenida D. Joo II, Lote
1.06.2.2 C - 7.3 e 7.4
1990-095 Lisboa
Portugal
Portugal

Peseri Trading Limited


20 Queen Frederica Street

tablet

El-Greco House, office 301


1066 Nicosia
Cyprus
Portugal

Peseri Trading Limited

Desloratadine

Desloratadina Peseri

5 mg

20 Queen Frederica Street

Orodispersible

Oral use

tablet

El-Greco House, office 301


1066 Nicosia
Cyprus
Portugal

Peseri Trading Limited

Desloratadine

Desloratadina Peseri

20 Queen Frederica Street

2,5 mg

Orodispersible

Oral use

tablet

El-Greco House, office 301


1066 Nicosia
Cyprus

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EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Pharmakern Portugal -

INN

Trimetazidine

Invented name

Trimetazidina Pharmakern

Strength

35 mg

Produtos Farmacuticos,

Pharmaceutical

Route of

Form

administration

Modified - release

Oral use

tablet

Sociedade Unipessoal, Lda.


Edifcio Atlas II, Av. Jos
Gomes Ferreira, N. 11 - 3,
Sala 31 - Miraflores
1495-139 Algs
Portugal
Portugal

Ratiopharm - Comrcio e

Desloratadine

Desloratadina Ratiopharm

2,5 mg

Indstria de Produtos

Orodispersible

Oral use

tablet

Farmacuticos, Lda.
Lagoas Park, Edifcio 5 A, Piso
2
2740-245 Porto Salvo
Portugal
Portugal

Ratiopharm - Comrcio e

Desloratadine

Desloratadina Ratiopharm

Indstria de Produtos

5 mg

Orodispersible

Oral use

tablet

Farmacuticos, Lda.
Lagoas Park, Edifcio 5 A, Piso
2
2740-245 Porto Salvo
Portugal

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Member State

Marketing Authorisation

(in EEA)

Holder

Portugal

Sandoz Farmaceutica Lda.

INN

Trimetazidine

Invented name

Trimetazidina Itraxel

Strength

35 mg

Avenida Professor Doutor

Pharmaceutical

Route of

Form

administration

Prolonged -

Oral use

release tablet

Cavaco Silva, n. 10E


Taguspark
2740-255 Porto Salvo
Portugal
Portugal

Teva Pharma - Produtos

Desloratadine

Desloratadina Teva

2,5 mg

Farmacuticos,Lda.

Orodispersible

Oral use

tablet

Edificio Tejo, Rua Quinta do


Pinheiro, 16 - 6
2790-143 Carnaxide
Portugal
Portugal

Teva Pharma - Produtos

Desloratadine

Desloratadina Teva

5 mg

Farmacuticos,Lda.

Orodispersible

Oral use

tablet

Edificio Tejo, Rua Quinta do


Pinheiro, 16 - 6
2790-143 Carnaxide
Portugal
Romania

Abbott Products SAS

Escitalopram

42 rue Rouget de Lisle

SAVANDRA 5 mg

5 mg

comprimate filmate

Film - coated

Oral use

tablet

92150 Suresnes
France
Romania

Abbott Products SAS


42 rue Rouget de Lisle

Escitalopram

SAVANDRA 10 mg
comprimate filmate

10 mg

Film - coated

Oral use

tablet

92150 Suresnes
France

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Member State

Marketing Authorisation

(in EEA)

Holder

Romania

Abbott Products SAS

INN

Escitalopram

42 rue Rouget de Lisle

Invented name

SAVANDRA 15 mg

Strength

15 mg

comprimate filmate

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

92150 Suresnes
France
Romania

Abbott Products SAS

Escitalopram

42 rue Rouget de Lisle

SAVANDRA 20 mg

20 mg

comprimate filmate

Film - coated

Oral use

tablet

92150 Suresnes
France
Romania

Alkaloid - INT d.o.o.

Cefpodoxime

landrova 4

Forexo 200 mg

200 mg

Tablet

Oral use

5 mg

Film - coated

Oral use

comprimate filmate

1231 Ljubljana - rnue


Slovenia
Romania

Alvogen IPCo S.ar.l.

Desloratadine

Rue Heienhaff 5

Desloratadina Alvogen 5
mg comprimate filmate

tablet

L-1736 Senningerberg
Luxembourg
Romania

Dr. Reddys Laboratories

Levetiracetam

Levetiracetam Dr. Reddys,

Romania SRL

250 mg, comprimate

71st-73rd Nicolae Caramfil,

filmate

250 mg

Tablet

Oral use

500 mg

Tablet

Oral use

Floor 5, Space 10, Sector 1,


Bucuresti, Romania
Romania

Dr. Reddys Laboratories

Levetiracetam

Levetiracetam Dr. Reddys,

Romania SRL

500mg, comprimate

71st-73rd Nicolae Caramfil,

filmate

Floor 5, Space 10, Sector 1,


Bucuresti, Romania

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Member State

Marketing Authorisation

(in EEA)

Holder

Romania

Dr. Reddys Laboratories

INN

Levetiracetam

Invented name

Levetiracetam Dr. Reddys,

Romania SRL

750 mg, comprimate

71st-73rd Nicolae Caramfil,

filmate

Pharmaceutical

Route of

Form

administration

750 mg

Tablet

Oral use

1000 mg

Tablet

Oral use

40 mg

Tablet

Oral use

80 mg

Tablet

Oral use

Tablet

Oral use

Strength

Floor 5, Space 10, Sector 1,


Bucuresti, Romania
Romania

Dr. Reddys Laboratories

Levetiracetam

Levetiracetam Dr. Reddys,

Romania SRL

1000 mg, comprimate

71st-73rd Nicolae Caramfil,

filmate

Floor 5, Space 10, Sector 1,


Bucuresti, Romania
Romania

Dr. Reddys Laboratories

Telmisartan

Romania SRL

Telmisartan Dr. Reddy's 40


mg comprimate

71st-73rd Nicolae Caramfil,


Floor 5, Space 10, Sector 1,
Bucuresti, Romania
Romania

Dr. Reddys Laboratories

Telmisartan

Romania SRL

Telmisartan Dr. Reddy's 80


mg comprimate

71st-73rd Nicolae Caramfil,


Floor 5, Space 10, Sector 1,
Bucuresti, Romania
Romania

Dr. Reddys Laboratories

Telmisartan/

Telmisartan HCT Dr.

40 mg/12,5

Romania SRL

hydrochlorothiazide

Reddys 40 mg/12,5 mg

mg

71st-73rd Nicolae Caramfil,

comprimate

Floor 5, Space 10, Sector 1,


Bucuresti, Romania

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Member State

Marketing Authorisation

(in EEA)

Holder

Romania

Dr. Reddys Laboratories

Telmisartan/

Telmisartan HCT Dr.

80 mg/12,5

Romania SRL

hydrochlorothiazide

Reddys 80 mg/12,5 mg

mg

INN

71st-73rd Nicolae Caramfil,

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Tablet

Oral use

Tablet

Oral use

Gastro - resistant

Oral use

comprimate

Floor 5, Space 10, Sector 1,


Bucuresti, Romania
Romania

Dr. Reddys Laboratories

Telmisartan/

Telmisartan HCT Dr.

80 mg/25

Romania SRL

hydrochlorothiazide

Reddys 80 mg/25 mg

mg

71st-73rd Nicolae Caramfil,

comprimate

Floor 5, Space 10, Sector 1,


Bucuresti, Romania
Romania

Generics (UK) Ltd

Esomeprazole

Esomeprazol Mylan 20 mg

Station Close, Potters Bar

magnesium

capsule gastrorezistente

Generics (UK) Ltd

Esomeprazole

Esomeprazol Mylan 40 mg

Station Close, Potters Bar

magnesium

capsule gastrorezistente

Generics (UK) Ltd

Donepezil

Donepezil Mylan 5 mg

Station Close, Potters Bar

hydrochloride

comprimate

20 mg

capsule, hard

Hertfordshire, EN6 1TL


United Kingdom
Romania

40 mg

Gastro - resistant

Oral use

capsule, hard

Hertfordshire, EN6 1TL


United Kingdom
Romania

Hertfordshire, EN6 1TL

5 mg

Orodispersible

Oral use

tablet

orodispersabile

United Kingdom
Romania

Generics (UK) Ltd

Donepezil

Donepezil Mylan 10 mg

Station Close, Potters Bar

hydrochloride

comprimate

Hertfordshire, EN6 1TL

10 mg

Orodispersible

Oral use

tablet

orodispersabile

United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

Romania

Generics (UK) Ltd

INN

Repaglinide

Station Close, Potters Bar

Invented name

Repaglinida Generics 0.5

Pharmaceutical

Route of

Form

administration

0,5 mg

Tablet

Oral use

1 mg

Tablet

Oral use

2 mg

Tablet

Oral use

4 mg

Tablet

Oral use

8 mg

Tablet

Oral use

16 mg

Tablet

Oral use

Strength

mg comprimate

Hertfordshire, EN6 1TL


United Kingdom
Romania

Generics (UK) Ltd

Repaglinide

Station Close, Potters Bar

Repaglinida Genericsl 1 mg
comprimate

Hertfordshire, EN6 1TL


United Kingdom
Romania

Generics (UK) Ltd

Repaglinide

Station Close, Potters Bar

Repaglinida Generics 2 mg
comprimate

Hertfordshire, EN6 1TL


United Kingdom
Romania

Generics (UK) Ltd

Candesartan

Candesartan Mylan 4 mg

Station Close, Potters Bar

cilexetil

comprimate

Generics (UK) Ltd

Candesartan

Candesartan Mylan 8 mg

Station Close, Potters Bar

cilexetil

comprimate

Generics (UK) Ltd

Candesartan

Candesartan Mylan 16 mg

Station Close, Potters Bar

cilexetil

comprimate

Hertfordshire, EN6 1TL


United Kingdom
Romania

Hertfordshire, EN6 1TL


United Kingdom
Romania

Hertfordshire, EN6 1TL


United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

Romania

Generics (UK) Ltd

Rizatriptan

Rizatriptan Mylan 5 mg

Station Close, Potters Bar

benzoate

comprimate

INN

Hertfordshire, EN6 1TL

Invented name

Strength

5 mg

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

orrodispersabile

United Kingdom
Romania

Generics (UK) Ltd

Rizatriptan

Rizatriptan Mylan 10 mg

Station Close, Potters Bar

benzoate

comprimate

Hertfordshire, EN6 1TL

10 mg

Orodispersible

Oral use

tablet

orrodispersabile

United Kingdom
Romania

Glenmark Pharmaceuticals

Trimetazidine

Apstar 35mg

s.r.o.

Comprimate cu

Hvzdova 1716/2b

eliberare

14078 Praha 4

prelungit

35 mg

Modified - release

Oral use

tablet

Czech Republic
Romania

Labormed Pharma SA

Desloratadine

Desloratadine Labormed

Bd. Theodor Pallady nr. 44 B

2.5 mg comprimate

032266, sector 3, Bucureti

orodispersabile

2,5 mg

Orodispersible

Oral use

tablet

Romnia
Romania

Labormed Pharma SA

Desloratadine

Desloratadine Labormed 5

Bd. Theodor Pallady nr. 44 B

mg comprimate

032266, sector 3, Bucureti

orodispersabile

5 mg

Orodispersible

Oral use

tablet

Romnia
Romania

Mylan SAS

Trimetazidine

Trimetazidina Mylan 35 mg

117 alle des Parcs

comprimate filmate cu

69792 Saint-Priest Cedex

eliberare prelungita

35 mg

Prolonged -

Oral use

release tablet

France

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Member State

Marketing Authorisation

(in EEA)

Holder

Romania

Sandoz Pharma Services SRL

INN

Trimetazidine

Invented name

Trimeluzine Limited 35 mg

Calea Floreasca Street

comprimate filmate cu

No 169A, district 2

eliberare modificata

Strength

35 mg

Pharmaceutical

Route of

Form

administration

Modified - release

Oral use

tablet

Bucharest
Romania
Romania

STADA Hemofarm S.R.L.

Entacapone

Calea Torontalului km 6 -

ENTTANIDA 200

200 mg

comprimate filmate

Film - coated

Oral use

tablet

PITT
300633 Timioara
Romania
Romania

Teva Pharmaceuticals S.R.L.

Desloratadine

Desloratadina Teva 5 mg

Str. Domnia Ruxandra nr.

comprimate

12, parter, sector 2,

orodispersabile

5 mg

Orodispersible

Oral use

tablet

Bucureti, Romnia
Romania

Torrent Pharma SRL

Irbesartan

Irbesartan Torrent 75 mg

Str. Stirbei Voda nr. 36

comprimate

et. 2, biroul A, sector 1

filmate

75 mg

Film - coated

Oral use

tablet

Bucharest
Romania
Romania

Torrent Pharma SRL

Irbesartan

Irbesartan Torrent 150 mg

Str. Stirbei Voda nr. 36

comprimate

et. 2, biroul A, sector 1

filmate

150 mg

Film - coated

Oral use

tablet

Bucharest
Romania

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Romania

Torrent Pharma SRL

INN

Irbesartan

Invented name

Irbesartan Torrent 300 mg

Str. Stirbei Voda nr. 36

comprimate

et. 2, biroul A, sector 1

filmate

Strength

300 mg

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

Bucharest
Romania
Romania

Torrent Pharma SRL

Irbesartan/hydroch

Irbesartan Torrent

150

Film - coated

Str. Stirbei Voda nr. 36

lorothiazide

Hidrochlorotiazida

mg/12,5

tablet

et. 2, biroul A, sector 1

150/12,5mg comprimate

mg

Bucharest

filmate

Oral use

Romania
Romania

Torrent Pharma SRL

Irbesartan/hydroch

Irbesartan Torrent

300

Film - coated

Str. Stirbei Voda nr. 36

lorothiazide

tablet

Hidrochlorotiazida

mg/12,5

et. 2, biroul A, sector 1

300/12,5mg comprimate

mg

Bucharest

filmate

Oral use

Romania
Romania

Torrent Pharma SRL

Irbesartan/hydroch

Irbesartan Torrent

300 mg/25

Film - coated

Str. Stirbei Voda nr. 36

lorothiazide

Hidrochlorotiazida

mg

tablet

200 mg

Film - coated

et. 2, biroul A, sector 1

300/25 mg comprimate

Bucharest

filmate

Oral use

Romania
Slovak Republic

Alkaloid - INT d.o.o.


landrova 4

Cefpodoxime

FOREXO 200 mg filmom


obalen tablety

Oral use

tablet

1231 Ljubljana - rnue


Slovenia

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Slovak Republic

Alvogen IPCo S.r.l.

INN

Desloratadine

412F Route d'Esch

Invented name

Dezloratadin Alvogen 5 mg

Strength

5 mg

filmom obalen tablety

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

L - 2086
Luxembourg
Slovak Republic

Genericon s.r.o.,

Desloratadine

GESLORA 5 mg

5 mg

Anny Letensk 1108/15,

Film - coated

Oral use

tablet

120 00 Praha 2 - Vinohrady


Czech Republic
Slovak Republic

Generics (UK) Ltd

Donepezil

Donepezil Mylan 5 mg

Station Close, Potters Bar

hydrochloride

orodispergovaten tablety

Generics (UK) Ltd

Donepezil

Donepezil Mylan 10 mg

Station Close, Potters Bar

hydrochloride

orodispergovaten tablety

Generics (UK) Ltd

Rizatriptan

Rizatriptan Mylan 10 mg

Station Close, Potters Bar

benzoate

5 mg

Orodispersible

Oral use

tablet

Hertfordshire, EN6 1TL


United Kingdom
Slovak Republic

10 mg

Orodispersible

Oral use

tablet

Hertfordshire, EN6 1TL


United Kingdom
Slovak Republic

10 mg

Orodispersible

Oral use

tablet

Hertfordshire, EN6 1TL


United Kingdom
Slovak Republic

Glenmark Pharmaceuticals
s.r.o.

Trimetazidine

Apstar 35 mg tablety s
predenm uvoovanm

35 mg

Modified - release

Oral use

tablet

Hvzdova 1716/2b
14078 Praha 4
Czech Republic

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Member State

Marketing Authorisation

(in EEA)

Holder

Slovak Republic

Mylan SAS

INN

Trimetazidine

Invented name

Trimetazidin Mylan 35 mg

Strength

35 mg

117 alle des Parcs

Pharmaceutical

Route of

Form

administration

Modified - release

Oral use

tablet

69792 Saint-Priest Cedex


France
Slovak Republic

SVUS Pharma a.s.

Desloratadine

Smetanovo nbe 1238/20a

LOTERA 5 mg filmom

5 mg

obalen tablety

Film - coated

Oral use

tablet

500 02 Hradec Krlov


Czech Republic
Slovak Republic

Teva Pharmaceuticals

Desloratadine

Slovakia s.r.o.

Dezloratadin Teva OROTAB

2,5 mg

2,5 mg

Orodispersible

Oral use

tablet

Teslova 26
821 02 Bratislava
Slovak Republic
Slovak Republic

Teva Pharmaceuticals

Desloratadine

Slovakia s.r.o.

Dezloratadin Teva OROTAB

5 mg

5 mg

Orodispersible

Oral use

tablet

Teslova 26
821 02 Bratislava
Slovak Republic
Slovenia

Alkaloid - INT d.o.o.

Cefpodoxime

landrova 4

Trexodo 200 mg filmsko

200 mg

obloene tablete

Film - coated

Oral use

tablet

1231 Ljubljana - rnue


Slovenia
Slovenia

Generics (UK) Ltd

Esomeprazole

Esomeprazol Mylan 20 mg

Station Close, Potters Bar

magnesium

trde gastrorezistentne

Hertfordshire, EN6 1TL

20 mg

Gastro - resistant

Oral use

capsule, hard

kapsule

United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Slovenia

Generics (UK) Ltd

Esomeprazole

Esomeprazol Mylan 40 mg

Station Close, Potters Bar

magnesium

trde gastrorezistentne

INN

Hertfordshire, EN6 1TL

Invented name

Strength

40 mg

Pharmaceutical

Route of

Form

administration

Gastro - resistant

Oral use

capsule, hard

kapsule

United Kingdom
Slovenia

Generics (UK) Ltd

Donepezil

Donepezil Mylan 5 mg

Station Close, Potters Bar

hydrochloride

orodisperzibilne tablete

Generics (UK) Ltd

Donepezil

Donepezil Mylan 10 mg

Station Close, Potters Bar

hydrochloride

orodisperzibilne tablete

Lek farmacevtska druba d.d.

Trimetazidine

Trimeluzine 35 mg tablete

Verovkova 57

hydrochloride

s podaljanim sproanjem

Metoclopramide

METOCLOPRAMIDA

5 mg

Orodispersible

Oral use

tablet

Hertfordshire, EN6 1TL


United Kingdom
Slovenia

10 mg

Orodispersible

Oral use

tablet

Hertfordshire, EN6 1TL


United Kingdom
Slovenia

35 mg

Prolonged -

Oral use

release tablet

1526 Ljubljana
Slovenia
Spain

Accord Healthcare, S.L.U.


Moll de Barcelona s/n. World

ACCORD 10 mg

Trade Center. Edifici Est 6

COMPRIMIDOS EFG

10 mg

Tablet

Oral use

Film - coated

Oral use

planta,
8039 Barcelona
Spain
Spain

Apotex Europe B.V.

Desloratadine

DESLORATADINA APOTEX

Darwinweg 20

5 mg COMPRIMIDOS

NL 2333 CR Leiden

RECUBIERTOS CON

Netherlands

PELICULA EFG

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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5 mg

tablet

Page 97/131

Member State

Marketing Authorisation

(in EEA)

Holder

Spain

Brown & Burk UK, Ltd.

INN

Ebastine

Invented name

EBASTINA BROWN 10 mg

5, Marryat Close

COMPRIMIDOS

Hounslow

BUCODISPERSABLES EFG

Strength

10 mg

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

TW4 5DQ Middlesex


United Kingdom
Spain

Farmalider, S.A.

Valsartan/hydrochl

VALSARTAN/HIDROCLORO

160

Film - coated

Aragoneses 15

orothiazide

TIAZIDA CODRAMOL 160

mg/12,5

tablet

28108 Madrid

MG/12,5 mg

mg

Spain

COMPRIMIDOS

Oral use

RECUBIERTOS CON
PELICULA EFG
Spain

Farmalider, S.A.

Valsartan/hydrochl

VALSARTAN/HIDROCLORO

160 mg/25

Film - coated

Aragoneses 15

orothiazide

TIAZIDA CODRAMOL

mg

tablet

28108 Madrid

160/25 mg COMPRIMIDOS

Spain

RECUBIERTOS CON

Oral use

PELICULA EFG
Spain

Farmalider, S.A.

Valsartan/hydrochl

VALSARTAN/HIDROCLORO

320

Film - coated

Aragoneses 15

orothiazide

TIAZIDA CODRAMOL

mg/12,5

tablet

28108 Madrid

320/12.5 mg

mg

Spain

COMPRIMIDOS

Oral use

RECUBIERTOS CON
PELICULA EFG
Spain

Farmalider, S.A.

Valsartan/hydrochl

VALSARTAN/HIDROCLORO

320 mg/25

Film - coated

Aragoneses 15

orothiazide

TIAZIDA CODRAMOL

mg

tablet

28108 Madrid

320/25 mg COMPRIMIDOS

Spain

RECUBIERTOS CON

Oral use

PELICULA EFG
GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Spain

Farmalider, S.A.

Valsartan/hydrochl

VALSARTAN/HIDROCLORO

Aragoneses 15

orothiazide

TIAZIDA CODRAMOL

INN

Invented name

28108 Madrid

80/12.5 mg COMPRIMIDOS

Spain

RECUBIERTOS CON

Pharmaceutical

Route of

Form

administration

80 mg/12,5

Film - coated

Oral use

mg

tablet

5 mg

Film - coated

Strength

PELICULA EFG
Spain

Laboratorios Combix, S.L.U.

Desloratadine

DESLORATADINA COMBIX

C/ Badajoz 2, Edificio 2

5 mg COMPRIMIDOS

Pozuelo de Alarcon

RECUBIERTOS CON

Madrid 28223

PELCULA EFG

Oral use

tablet

Spain
Spain

Laboratorios Combix, S.L.U.

Desloratadine

DESLORATADINA FLAS

C/ Badajoz 2, Edificio 2

COMBIX 5 mg

Pozuelo de Alarcon

COMPRIMIDOS

Madrid 28223

BUCODISPERSABLES EFG

5 mg

Film - coated

Oral use

tablet

Spain
Spain

Laboratorios Combix, S.L.U.

Escitalopram

ESCITALOPRAM COMBIX

C/ Badajoz 2, Edificio 2

10 mg COMPRIMIDOS

Pozuelo de Alarcon

RECUBIERTOS CON

Madrid 28223

PELICULA EFG

10 mg

Film - coated

Oral use

tablet

Spain
Spain

Laboratorios Combix, S.L.U.

Escitalopram

ESCITALOPRAM COMBIX

C/ Badajoz 2, Edificio 2

15 mg COMPRIMIDOS

Pozuelo de Alarcon

RECUBIERTOS CON

Madrid 28223

PELICULA EFG

15 mg

Film - coated

Oral use

tablet

Spain

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

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Member State

Marketing Authorisation

(in EEA)

Holder

Spain

Laboratorios Combix, S.L.U.

INN

Escitalopram

Invented name

ESCITALOPRAM COMBIX

C/ Badajoz 2, Edificio 2

20 mg COMPRIMIDOS

Pozuelo de Alarcon

RECUBIERTOS CON

Madrid 28223

PELICULA EFG

Strength

20 mg

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

Spain
Spain

Laboratorios Combix, S.L.U.

Escitalopram

ESCITALOPRAM COMBIX 5

C/ Badajoz 2, Edificio 2

mg COMPRIMIDOS

Pozuelo de Alarcon

RECUBIERTOS CON

Madrid 28223

PELICULA EFG

5 mg

Film - coated

Oral use

tablet

Spain
Spain

Laboratorios Ranbaxy, S. L U.

Alendronic acid

ACIDO ALENDRONICO

Paseig de Gracia 9

SEMANAL RANBAXY 70 mg

7a Pl

COMPRIMIDOS EFG

70 mg

Tablet

Oral use

10 mg

Orodispersible

Oral use

Barcelona 08007
Spain
Spain

Mylan Pharmaceuticals, S.L.

Donepezil

Plom 2-4, 5 Planta

PHARMACEUTICALS 10 mg

8038 Barcelona

COMPRIMIDOS

Spain
Spain

DONEPEZILO FLAS MYLAN

Mylan Pharmaceuticals, S.L.

tablet

BUCODISPERSABLES EFG
Donepezil

DONEPEZILO FLAS MYLAN

Plom 2-4, 5 Planta

PHARMACEUTICALS 5 mg

8038 Barcelona

COMPRIMIDOS

Spain

BUCODISPERSABLES EFG

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

5 mg

Orodispersible

Oral use

tablet

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Member State

Marketing Authorisation

(in EEA)

Holder

Spain

Mylan Pharmaceuticals, S.L.

INN

Esomeprazole

mg CAPSULAS

8038 Barcelona

GASTRORRESISTENTES

Mylan Pharmaceuticals, S.L.

ESOMEPRAZOL MYLAN 40

Plom 2-4, 5 Planta

mg CAPSULAS

8038 Barcelona

GASTRORRESISTENTES

Mylan Pharmaceuticals, S.L.

Strength

20 mg

Pharmaceutical

Route of

Form

administration

Gastro - resistant

Oral use

capsule

EFG
Esomeprazole

Spain
Spain

ESOMEPRAZOL MYLAN 20

Plom 2-4, 5 Planta


Spain
Spain

Invented name

40 mg

Gastro - resistant

Oral use

capsule

EFG
Repaglinide

Plom 2-4, 5 Planta

REPAGLINIDA MYLAN 0,5

0,5 mg

Tablet

Oral use

1 mg

Tablet

Oral use

2 mg

Tablet

Oral use

10 mg

Orodispersible

Oral use

mg COMPRIMIDOS EFG

8038 Barcelona
Spain
Spain

Mylan Pharmaceuticals, S.L.

Repaglinide

Plom 2-4, 5 Planta

REPAGLINIDA MYLAN 1 mg
COMPRIMIDOS EFG

8038 Barcelona
Spain
Spain

Mylan Pharmaceuticals, S.L.

Repaglinide

Plom 2-4, 5 Planta

REPAGLINIDA MYLAN 2 mg
COMPRIMIDOS EFG

8038 Barcelona
Spain
Spain

Mylan Pharmaceuticals, S.L.

Rizatriptan

RIZATRIPTAN MAX MYLAN

Plom 2-4, 5 Planta

10 mg COMPRIMIDOS

8038 Barcelona

BUCODISPERSABLES EFG

tablet

Spain

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Spain

PENSA PHARMA, S.A.U

INN

Alendronic acid

Invented name

ACIDO ALENDRONICO

Jorge Comn (mdico

SEMANAL PENSA 70 mg

pediatra)

COMPRIMIDOS EFG

Pharmaceutical

Route of

Form

administration

70 mg

Tablet

Oral use

2,5 mg

Orodispersible

Oral use

Strength

3 - bajos
46015 Valencia (Valencia)
Spain
Spain

Pharmagenus, S.A.,

Desloratadine

DESLORATADINA

Avda. Cam Real, 51-57,

PHARMAGENUS 2,5 mg

08184 Palau-solita i

COMPRIMIDOS

Plegamans (Barcelona)

BUCODISPERSABLES EFG

tablet

Spain
Spain

Pharmagenus, S.A.,

Desloratadine

DESLORATADINA

Avda. Cam Real, 51-57,

PHARMAGENUS 5 mg

08184 Palau-solita i

COMPRIMIDOS

Plegamans (Barcelona)

BUCODISPERSABLES EFG

5 mg

Orodispersible

Oral use

tablet

Spain
Spain

Teva Pharma S.L.U.

Desloratadine

DESLORATADINA TEVA 5

C/ Anabel Segura, 11

mg COMPRIMIDOS

Edificio Albatros B, 1 planta

BUCODISPERSABLES EFG

5 mg

Orodispersible

Oral use

tablet

Madrid 28108
Spain
Spain

Welding GmbH & Co. KG

Irbesartan

IRBESARTAN/HIDROCLOR

150

Film - coated

Esplanade 39

OTIAZIDA WELDING 150

mg/12,5

tablet

D-20354 Hamburg

mg/12.5 mg

mg

Germany

COMPRIMIDOS

Oral use

RECUBIERTOS CON
PELICULA EFG
GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Spain

Welding GmbH & Co. KG

INN

Irbesartan

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Oral use

IRBESARTAN/HIDROCLOR

300

Film - coated

Esplanade 39

OTIAZIDA WELDING 300

mg/12,5

tablet

D-20354 Hamburg

mg/12.5 mg

mg

Germany

COMPRIMIDOS
RECUBIERTOS CON
PELICULA EFG

Spain

Welding GmbH & Co. KG

Irbesartan

IRBESARTAN/HIDROCLOR

300 mg/25

Film - coated

Oral use

Esplanade 39

OTIAZIDA WELDING 300

mg

tablet

D-20354 Hamburg

mg/25 mg COMPRIMIDOS

Germany

RECUBIERTOS CON
70 mg

Tablet

Oral use

Clindamycin Alternova

150 mg

Capsule, hard

Oral use

Fluconazol Bluefish

50 mg

Capsule, hard

Oral use

PELICULA EFG
Sweden

Accord Healthcare Limited

Alendronic acid

Sage House, 319 Pinner Road

Alendronat Accord
Veckotablett

North Harrow HA1 4HF


Middlesex
United Kingdom
Sweden

Alternova A/S

Clindamycin

Lodshusvej 11

hydrochloride

DK-4230 Sklskr
Denmark
Sweden

Bluefish Pharmaceuticals AB

Fluconazole

Torsgatan 11
SE-11123 Stockholm
Sweden

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Member State

Marketing Authorisation

(in EEA)

Holder

Sweden

Bluefish Pharmaceuticals AB

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Fluconazole

Fluconazol Bluefish

150 mg

Capsule, hard

Oral use

Fluconazole

Fluconazol Bluefish

200 mg

Capsule, hard

Oral use

Generics (UK) Ltd

Donepezil

Donezil

5 mg

Orodispersible

Oral use

Station Close, Potters Bar

hydrochloride

Torsgatan 11
SE-11123 Stockholm
Sweden
Sweden

Bluefish Pharmaceuticals AB
Torsgatan 11
SE-11123 Stockholm
Sweden

Sweden

tablet

Hertfordshire, EN6 1TL


United Kingdom
Sweden

Generics (UK) Ltd

Donepezil

Station Close, Potters Bar

hydrochloride

Donezil

10 mg

Orodispersible

Oral use

tablet

Hertfordshire, EN6 1TL


United Kingdom
Sweden

Mylan AB

Donepezil

Donepezil Mylan

5 mg

PO Box 230 33

Orodispersible

Oral use

tablet

SE-104 35 Stockholm
Sweden
Sweden

Mylan AB

Donepezil

Donepezil Mylan

PO Box 230 33

10 mg

Orodispersible

Oral use

tablet

SE-104 35 Stockholm
Sweden

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Sweden

Mylan AB

INN

Rizatriptan

Invented name

Rizatriptan Mylan

Strength

10 mg

PO Box 230 33

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

SE-104 35 Stockholm
Sweden
Sweden

Mylan AB

Repaglinide

Repaglinid Mylan

0,5 mg

Tablet

Oral use

Repaglinide

Repaglinid Mylan

1 mg

Tablet

Oral use

Repaglinide

Repaglinid Mylan

2 mg

Tablet

Oral use

Esomeprazole

Esomeprazol Mylan

20 mg

Gastro - resistant

Oral use

PO Box 230 33
SE-104 35 Stockholm
Sweden
Sweden

Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden

Sweden

Mylan AB
PO Box 230 33
SE-104 35 Stockholm
Sweden

Sweden

Mylan AB
PO Box 230 33

capsule, hard

SE-104 35 Stockholm
Sweden
Sweden

Mylan AB

Esomeprazole

Esomeprazol Mylan

PO Box 230 33

40 mg

Gastro - resistant

Oral use

capsule, hard

SE-104 35 Stockholm
Sweden

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Sweden

Mylan AB

INN

Eletriptan

Invented name

Eletriptan Mylan

Strength

20 mg

PO Box 230 33

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

SE-104 35 Stockholm
Sweden
Sweden

Mylan AB

Eletriptan

Eletriptan Mylan

40 mg

PO Box 230 33

Film - coated

Oral use

tablet

SE-104 35 Stockholm
Sweden
Sweden

Orion Corporation

Valsartan

Valsartan Orion

40 mg

Orion Pharma

Film - coated

Oral use

tablet

PO BOX 65
02101 Espoo
Finland
Sweden

Orion Corporation

Valsartan

Valsartan Orion

80 mg

Orion Pharma

Film - coated

Oral use

tablet

PO BOX 65
02101 Espoo
Finland
Sweden

Orion Corporation

Valsartan

Valsartan Orion

Orion Pharma

160 mg

Film - coated

Oral use

tablet

PO BOX 65
02101 Espoo
Finland

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

Sweden

Orion Corporation

INN

Valsartan

Invented name

Valsartan Orion

Strength

320 mg

Orion Pharma

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

PO BOX 65
02101 Espoo
Finland
Sweden

Ranbaxy UK Ltd.

Alendronic acid

Alendronat Ranbaxy

Building 4, Chiswick Park

Veckotablett 70 mg

566 Chiswick High Road

tabletter

70 mg

Tablet

Oral use

200 mg

Film - coated

Oral use

London, W4 5YE
Untied Kingdom
Sweden

Stada Arzneimittel AG

Entacapone

Entakapon STADA

Stadastrasse 2-18

tablet

DE-61118 Bad Vilbel


Germany
The

Accord Healthcare Limited

Netherlands

Sage House, 319 Pinner Road

Ropinirole

Ropinirol Accord 5 mg,

5 mg

filmomhulde tabletten

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
The

Accord Healthcare Limited

Netherlands

Sage House, 319 Pinner Road

Ropinirole

Ropinirol Accord 0,25 mg


filmomhulde tabletten

0,25 mg

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

The

Accord Healthcare Limited

Netherlands

Sage House, 319 Pinner Road

INN

Ropinirole

Invented name

Ropinirol Accord 0,5 mg

Strength

0,5 mg

filmomhulde tabletten

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
The

Accord Healthcare Limited

Netherlands

Sage House, 319 Pinner Road

Ropinirole

Ropinirol Accord 1 mg

1 mg

filmomhulde tabletten

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
The

Accord Healthcare Limited

Netherlands

Sage House, 319 Pinner Road

Ropinirole

Ropinirol Accord 2 mg

2 mg

filmomhulde tabletten

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
The

Accord Healthcare Limited

Netherlands

Sage House, 319 Pinner Road

Alendronic acid

Alendroninezuur Accord

10 mg

Tablet

Oral use

70 mg

Tablet

Oral use

10mg Tabletten

North Harrow HA1 4HF


Middlesex
United Kingdom
The

Accord Healthcare Limited

Netherlands

Sage House, 319 Pinner Road

Alendronic acid

Alendroninezuur Accord
70mg Tabletten

North Harrow HA1 4HF


Middlesex
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

The

Accord Healthcare Limited

Metoclopramide

Metoclopramidemonohydro

Netherlands

Sage House, 319 Pinner Road

hydrochloride

chloride Accord 10 mg,

INN

North Harrow HA1 4HF

Invented name

Pharmaceutical

Route of

Form

administration

10 mg

Tablet

Oral use

37,5 mg

Prolonged -

Oral use

Strength

Tabletten

Middlesex
United Kingdom
The

Alembic Pharmaceuticals

Netherlands

Europe Limited

Alembic 37,5 mg, capsule

release capsule,

Palazzo Pietro Stiges, 103,

met verlengde afgifte, hard

hard

Venlafaxine

Venlafaxine HCl Retard

Strait Street
VLT 1436 Valletta
Malta
The

Alembic Pharmaceuticals

Netherlands

Europe Limited

Alembic 75 mg, capsule

release capsule,

Palazzo Pietro Stiges, 103,

met verlengde afgifte, hard

hard

Venlafaxine

Venlafaxine HCl Retard

75 mg

Prolonged -

Oral use

Strait Street
VLT 1436 Valletta
Malta
The

Alembic Pharmaceuticals

Netherlands

Europe Limited

Alembic 150 mg, capsule

release capsule,

Palazzo Pietro Stiges, 103,

met verlengde afgifte, hard

hard

Venlafaxine

Venlafaxine HCl Retard

150 mg

Prolonged -

Oral use

Strait Street
VLT 1436 Valletta
Malta

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

The

Brown & Burk UK, Ltd.

Netherlands

5, Marryat Close

orodispergeerbare

Hounslow

tabletten

INN

Ebastine

Invented name

Ebastine BB 10 mg

Strength

10 mg

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

TW4 5DQ Middlesex


United Kingdom
The

Centrafarm B.V.

Netherlands

Nieuwe Donk 3

Entacapone

Entacapone CF 200 mg,

200 mg

filmomhulde tablet

Film - coated

Oral use

tablet

4879 AC Etten Leur


The Netherlands
The

Fair-Med Healthcare GmbH

Netherlands

Planckstrasse 13

Ciprofloxacin

Ciprofloxacine Fair-Med
250 mg, filmomhulde

DE-22765 Hamburg

tabletten

250 mg

Film - coated

Oral use

tablet

Germany
The

Fair-Med Healthcare GmbH

Ciprofloxacin

Ciprofloxacine Fair-Med

Netherlands

Planckstrasse 13

500 mg, filmomhulde

DE-22765 Hamburg

tabletten

500 mg

Film - coated

Oral use

tablet

Germany
The

Fair-Med Healthcare GmbH

Ciprofloxacin

Ciprofloxacine Fair-Med

Netherlands

Planckstrasse 13

750 mg, filmomhulde

DE-22765 Hamburg

tabletten

750 mg

Film - coated

Oral use

tablet

Germany
The

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/HCTZ Fair-Med

160

Film - coated

Netherlands

Planckstrasse 13

orothiazide

160 mg/12,5 mg,

mg/12,5

tablet

filmomhulde tabletten

mg

DE-22765 Hamburg

Oral use

Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

The

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/HCTZ Fair-Med

Netherlands

Planckstrasse 13

orothiazide

INN

DE-22765 Hamburg

Pharmaceutical

Route of

Form

administration

320

Film - coated

Oral use

320 mg/12,5 mg,

mg/12,5

tablet

filmomhulde tabletten

mg

Invented name

Strength

Germany
The

Fair-Med Healthcare GmbH

Valsartan/hydrochl

Valsartan/HCTZ Fair-Med

320 mg/25

Film - coated

Netherlands

Planckstrasse 13

orothiazide

320 mg/25 mg,

mg

tablet

37,5 mg

Prolonged -

DE-22765 Hamburg

Oral use

filmomhulde tabletten

Germany
The

Fair-Med Healthcare GmbH

Venlafaxine

Venlafaxine Fair-Med 37,5

Netherlands

Planckstrasse 13

mg capsules met verlengde

release capsule,

DE-22765 Hamburg

afgifte, hard

hard

Oral use

Germany
The

Fair-Med Healthcare GmbH

Netherlands

Planckstrasse 13

Venlafaxine

mg capsules met verlengde

Venlafaxine Fair-Med 75

75 mg

Prolonged release capsule,

DE-22765 Hamburg

afgifte, hard

hard

Oral use

Germany
The

Fair-Med Healthcare GmbH

Netherlands

Planckstrasse 13

Venlafaxine

mg capsules met verlengde

Venlafaxine Fair-Med 150

150 mg

Prolonged release capsule,

DE-22765 Hamburg

afgifte, hard

hard

Oral use

Germany
The

Mylan B.V.

Esomeprazole

Esomeprazol Mylan 20 mg,

Netherlands

Dieselweg 25

maagsapresistente

3752 LB Bunschoten

capsules, hard

20 mg

Gastro - resistant

Oral use

capsule, hard

The Netherlands

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

The

Mylan B.V.

Netherlands

Dieselweg 25

maagsapresistente

3752 LB Bunschoten

capsules, hard

INN

Esomeprazole

Invented name

Esomeprazol Mylan 40 mg,

Strength

40 mg

Pharmaceutical

Route of

Form

administration

Gastro - resistant

Oral use

capsule, hard

The Netherlands
The

Mylan B.V.

Rizatriptan

Rizatriptan SmeltTab Mylan

Netherlands

Dieselweg 25

5 mg, orodispergeerbare

3752 LB Bunschoten

tabletten

5 mg

Orodispersible

Oral use

tablet

The Netherlands
The

Mylan B.V.

Rizatriptan

Rizatriptan SmeltTab Mylan

Netherlands

Dieselweg 25

10 mg, orodispergeerbare

3752 LB Bunschoten

tabletten

10 mg

Orodispersible

Oral use

tablet

The Netherlands
The

Ranbaxy UK Ltd.

Netherlands

Building 4, Chiswick Park

Alendronic acid

Alendroninezuur 70

70 mg

Tablet

Oral use

0,5 mg

Tablet

Oral use

2 mg

Tablet

Oral use

Ranbaxy, tabletten 70 mg

566 Chiswick High Road


London, W4 5YE
Untied Kingdom
The

Sandoz B.V.

Netherlands

Veluwezoom 22

Clonazepam

Clonazepam Sandoz 0,5


mg, tabletten

1327 AH Almere
The Netherlands
The

Sandoz B.V.

Netherlands

Veluwezoom 22

Clonazepam

Clonazepam Sandoz 2 mg,


tabletten

1327 AH Almere
The Netherlands

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

The

Sandoz B.V.

Netherlands

Veluwezoom 22

INN

Clobazam

Invented name

Clobazam Sandoz 10 mg,

Pharmaceutical

Route of

Form

administration

10 mg

Tablet

Oral use

2,5 mg

Orodispersible

Oral use

Strength

tabletten

1327 AH Almere
The Netherlands
The

Teva Nederland B.V.

Desloratadine

Netherlands

Swensweg 5

2,5 mg Teva,

2031 GA Haarlem

orodispergeerbare

The Netherlands

Desloratadine Smelttablet

tabletten

The

Teva Nederland B.V.

Netherlands

Swensweg 5

5 mg Teva,

2031 GA Haarlem

orodispergeerbare

The Netherlands

tabletten

The

TioFarma b.v.

Netherlands

Benjamin Franklinstraat 5-10

tablet

Desloratadine

Clonazepam

Desloratadine Smelttablet

Clonazepam TioFarma 0,5

5 mg

Orodispersible

Oral use

tablet

0,5 mg

Tablet

Oral use

2 mg

Tablet

Oral use

10 mg

Tablet

Oral use

mg tabletten, tabletten

3261 LW Oud-Beyerland
The Netherlands
The

TioFarma b.v.

Netherlands

Benjamin Franklinstraat 5-10

Clonazepam

Clonazepam TioFarma 2
mg tabletten, tabletten

3261 LW Oud-Beyerland
The Netherlands
The

TioFarma b.v.

Netherlands

Benjamin Franklinstraat 5-10

Clobazam

Clobazam TioFarma 10 mg,


tabletten

3261 LW Oud-Beyerland
The Netherlands

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

The

TioFarma b.v.

Netherlands

Benjamin Franklinstraat 5-10

INN

Clobazam

Invented name

Clobazam TioFarma 20 mg,

Pharmaceutical

Route of

Form

administration

20 mg

Tablet

Oral use

75 mg

Film - coated

Oral use

Strength

tabletten

3261 LW Oud-Beyerland
The Netherlands
The

Torrent Pharma GmbH

Netherlands

Sdwestpark 50

irbesartan

Irbesartan Torrent 75 mg
filmomhulde tabletten

tablet

90449 Nrnberg
Germany
The

Torrent Pharma GmbH

Netherlands

Sdwestpark 50

irbesartan

Irbesartan Torrent 150 mg

150 mg

filmomhulde tabletten

Film - coated

Oral use

tablet

90449 Nrnberg
Germany
The

Torrent Pharma GmbH

Netherlands

Sdwestpark 50

irbesartan

Irbesartan Torrent 300 mg

300 mg

filmomhulde tabletten

Film - coated

Oral use

tablet

90449 Nrnberg
Germany
The

Torrent Pharma GmbH

Irbesartan/hydroch

Irbesartan

150

Film - coated

Netherlands

Sdwestpark 50

lorothiazide

Hydrochloorthiazide

mg/12,5

tablet

90449 Nrnberg

Torrent 150 mg/12,5 mg

mg

Germany

filmomhulde tabletten

The

Torrent Pharma GmbH

Irbesartan/hydroch

Irbesartan

300

Film - coated

Netherlands

Sdwestpark 50

lorothiazide

Hydrochloorthiazide

mg/12,5

tablet

90449 Nrnberg

Torrent 300 mg/12,5 mg

mg

Germany

filmomhulde tabletten

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Oral use

Oral use

Page 114/131

Member State

Marketing Authorisation

(in EEA)

Holder

The

Torrent Pharma GmbH

Irbesartan/hydroch

Irbesartan

Netherlands

Sdwestpark 50

lorothiazide

Hydrochloorthiazide

INN

90449 Nrnberg
Unichem Laboratories Ltd.

Netherlands

Studio 8B Ard Gaoithe

Pharmaceutical

Route of

Form

administration

300 mg/25

Film - coated

Oral use

mg

tablet

150 mg

Film - coated

Strength

Torrent 300 mg/25 mg

Germany
The

Invented name

filmomhulde tabletten
irbesartan

Irbesartan Unichem 150


mg filmomhulde tabletten

Oral use

tablet

Commercial Centre, Business


Park
Cashel Road Clonmel,
Co Tipperary
Ireland
The

Unichem Laboratories Ltd.

Netherlands

Studio 8B Ard Gaoithe

irbesartan

Irbesartan Unichem 300

300 mg

mg filmomhulde tabletten

Film - coated

Oral use

tablet

Commercial Centre, Business


Park
Cashel Road Clonmel,
Co Tipperary
Ireland
United

Accord Healthcare Limited

Kingdom

Sage House, 319 Pinner Road

Ropinirole

Ropinirole 0.25mg filmcoated tablets

0,25 mg

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

United

Accord Healthcare Limited

Kingdom

Sage House, 319 Pinner Road

INN

Ropinirole

Invented name

Ropinirole 0.5mg film-

Strength

0,5 mg

coated tablets

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
United

Accord Healthcare Limited

Kingdom

Sage House, 319 Pinner Road

Ropinirole

Ropinirole 1mg film-coated

1 mg

tablets

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
United

Accord Healthcare Limited

Kingdom

Sage House, 319 Pinner Road

Ropinirole

Ropinirole 2mg film-coated

2 mg

tablets

Film - coated

Oral use

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
United

Accord Healthcare Limited

Kingdom

Sage House, 319 Pinner Road

Alendronic acid

alendronic acid 10mg

10 mg

Tablet

Oral use

70 mg

Tablet

Oral use

Tablets

North Harrow HA1 4HF


Middlesex
United Kingdom
United

Accord Healthcare Limited

Kingdom

Sage House, 319 Pinner Road

Alendronic acid

alendronic acid 70mg Once


Daily Tablets

North Harrow HA1 4HF


Middlesex
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

United

Accord Healthcare Limited

Metoclopramide

metoclopramide

Kingdom

Sage House, 319 Pinner Road

hydrochloride

hydrochloride 10mg tablets

Ropinirole

Ropinirole 5mg film-coated

INN

Invented name

Pharmaceutical

Route of

Form

administration

10 mg

Tablet

Oral use

5 mg

Film - coated

Oral use

Strength

North Harrow HA1 4HF


Middlesex
United Kingdom
United

Accord Healthcare Limited

Kingdom

Sage House, 319 Pinner Road

tablets

tablet

North Harrow HA1 4HF


Middlesex
United Kingdom
United

Aptil Pharma Limited

Kingdom

9th Floor, CP House

Fluconazole

Fluconazole 50mg capsules

50 mg

Capsule, hard

Oral use

Fluconazole

Fluconazole 150mg

150 mg

Capsule, hard

Oral use

200 mg

Capsule, hard

Oral use

97-107 Uxbridge Road


London W5 5TL
United Kingdom
United

Aptil Pharma Limited

Kingdom

9th Floor, CP House

capsules

97-107 Uxbridge Road


London W5 5TL
United Kingdom
United

Aptil Pharma Limited

Kingdom

9th Floor, CP House

Fluconazole

Fluconazole 200mg
capsules

97-107 Uxbridge Road


London W5 5TL
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

United

Auden McKenzie Limited

Kingdom

McKenzie House

INN

Dexamethasone

Pharmaceutical

Route of

Form

administration

2 mg

Tablet

Oral use

Tyvera 50mg Tablets

50 mg

Tablet

Oral use

Tyvera 100mg Tablets

100 mg

Tablet

Oral use

Clonazepam 500mcg

0,5 mg

Tablet

Oral use

2 mg

Tablet

Oral use

Invented name

Dexamethasone 2mg

Strength

Tablets

Bury Street, Ruislip


Middlesex HA4 7TL
United Kingdom
United

Auden McKenzie Limited

Thiamine

Kingdom

McKenzie House

hydrochloride

Bury Street, Ruislip


Middlesex HA4 7TL
United Kingdom
United

Auden McKenzie Limited

Thiamine

Kingdom

McKenzie House

hydrochloride

Bury Street, Ruislip


Middlesex HA4 7TL
United Kingdom
United

Auden McKenzie Limited

Kingdom

McKenzie House

Clonazepam

Tablet

Bury Street, Ruislip


Middlesex HA4 7TL
United Kingdom
United

Auden McKenzie Limited

Kingdom

McKenzie House

Clonazepam

Clonazepam 2mg Tablet

Bury Street, Ruislip


Middlesex HA4 7TL
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

United

Auden McKenzie Limited

Kingdom

McKenzie House

INN

Clobazam

Invented name

CLOBAZAM AUDEN 10mg

Pharmaceutical

Route of

Form

administration

10 mg

Tablet

Oral use

250 mg

Film - coated

Oral use

Strength

TABLETS

Bury Street, Ruislip


Middlesex HA4 7TL
United Kingdom
United

Brown & Burk UK, Ltd.

Phenoxymethyl

Phenoxymethylpenicillin

Kingdom

5, Marryat Close

penicillin

250mg Film-coated Tablets

tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom
United

Brown & Burk UK, Ltd.

Escitalopram

Escitalopram 5mg Film-

Kingdom

5, Marryat Close

oxalate

coated tablets

5 mg

Film - coated

Oral use

tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom
United

Brown & Burk UK, Ltd.

Escitalopram

Escitalopram 10mg Film-

Kingdom

5, Marryat Close

oxalate

coated tablets

10 mg

Film - coated

Oral use

tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom
United

Brown & Burk UK, Ltd.

Escitalopram

Escitalopram 15mg Film-

Kingdom

5, Marryat Close

oxalate

coated tablets

15 mg

Film - coated

Oral use

tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

United

Brown & Burk UK, Ltd.

Escitalopram

Escitalopram 20mg Film-

Kingdom

5, Marryat Close

oxalate

coated tablets

INN

Invented name

Strength

20 mg

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom
United

Brown & Burk UK, Ltd.

Tramadol

Aceon 100mg Prolonged-

Kingdom

5, Marryat Close

hydrochloride

release tablets

100 mg

Prolonged -

Oral use

release tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom
United

Brown & Burk UK, Ltd.

Tramadol

Aceon 150mg Prolonged-

Kingdom

5, Marryat Close

hydrochloride

release tablets

150 mg

Prolonged -

Oral use

release tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom
United

Brown & Burk UK, Ltd.

Tramadol

Aceon 200mg Prolonged-

Kingdom

5, Marryat Close

hydrochloride

release tablets

Valsartan

Valsartan 40mg Capsules

200 mg

Prolonged -

Oral use

release tablet

Hounslow
TW4 5DQ Middlesex
United Kingdom
United

Dr Reddy's Laboratories (UK)

Kingdom

Limited

40 mg

Capsule

Oral use

6 Riverview Road, Beverley


East Yorkshire HU17 0LD
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

United

Dr Reddy's Laboratories (UK)

Kingdom

Limited

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Valsartan

Valsartan 80mg Capsules

80 mg

Capsule

Oral use

Valsartan

Valsartan 160mg Capsules

160 mg

Capsule

Oral use

Valsartan

Valsartan 320mg Capsules

320 mg

Capsule

Oral use

Levetiracetam

Levetiracetam 250mg film-

250 mg

Film - coated

Oral use

6 Riverview Road, Beverley


East Yorkshire HU17 0LD
United Kingdom
United

Dr Reddy's Laboratories (UK)

Kingdom

Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom

United

Dr Reddy's Laboratories (UK)

Kingdom

Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom

United

Dr Reddy's Laboratories (UK)

Kingdom

Limited

coated tablets

tablet

6 Riverview Road, Beverley


East Yorkshire HU17 0LD
United Kingdom
United

Dr Reddy's Laboratories (UK)

Kingdom

Limited

Levetiracetam

Levetiracetam 500mg filmcoated tablets

500 mg

Film - coated

Oral use

tablet

6 Riverview Road, Beverley


East Yorkshire HU17 0LD
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

United

Dr Reddy's Laboratories (UK)

Kingdom

Limited

INN

Levetiracetam

Invented name

Levetiracetam 750mg film-

Strength

750 mg

coated tablets

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

6 Riverview Road, Beverley


East Yorkshire HU17 0LD
United Kingdom
United

Dr Reddy's Laboratories (UK)

Kingdom

Limited

Levetiracetam

Levetiracetam 1000mg

1000 mg

film-coated tablets

Film - coated

Oral use

tablet

6 Riverview Road, Beverley


East Yorkshire HU17 0LD
United Kingdom
United

Dr Reddy's Laboratories (UK)

Kingdom

Limited

Pioglitazone

Pioglitazone 15mg Tablets

15 mg

Tablet

Oral use

Pioglitazone

Pioglitazone 30mg Tablets

30 mg

Tablet

Oral use

Pioglitazone

Pioglitazone 45mg Tablets

45 mg

Tablet

Oral use

6 Riverview Road, Beverley


East Yorkshire HU17 0LD
United Kingdom
United

Dr Reddy's Laboratories (UK)

Kingdom

Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom

United

Dr Reddy's Laboratories (UK)

Kingdom

Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

United

Dr Reddy's Laboratories (UK)

Kingdom

Limited

INN

Dipyridamole

Invented name

Attia 200mg Modified

Strength

200 mg

Release Capsules

Pharmaceutical

Route of

Form

administration

Modified - release

Oral use

capsule, hard

6 Riverview Road, Beverley


East Yorkshire HU17 0LD
United Kingdom
United

Dr Reddy's Laboratories (UK)

Kingdom

Limited

Telmisartan

Telmisartan 20mg Tablets

20 mg

Tablet

Oral use

Telmisartan

Telmisartan 40mg Tablets

40 mg

Tablet

Oral use

Telmisartan

Telmisartan 80mg Tablets

80 mg

Tablet

Oral use

Tablet

Oral use

6 Riverview Road, Beverley


East Yorkshire HU17 0LD
United Kingdom
United

Dr Reddy's Laboratories (UK)

Kingdom

Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom

United

Dr Reddy's Laboratories (UK)

Kingdom

Limited
6 Riverview Road, Beverley
East Yorkshire HU17 0LD
United Kingdom

United

Dr Reddy's Laboratories (UK)

Telmisartan/

Telmisartan/Hydrochlorothi

40 mg/12,5

Kingdom

Limited

hydrochlorothiazide

azide 40mg/12.5mg

mg

6 Riverview Road, Beverley

Tablets

East Yorkshire HU17 0LD


United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

United

Dr Reddy's Laboratories (UK)

Telmisartan/

Telmisartan/Hydrochlorothi

80 mg/12,5

Kingdom

Limited

hydrochlorothiazide

azide 80mg/12.5mg

mg

INN

6 Riverview Road, Beverley

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Tablet

Oral use

Tablet

Oral use

Film - coated

Oral use

Tablets

East Yorkshire HU17 0LD


United Kingdom
United

Dr Reddy's Laboratories (UK)

Telmisartan/

Telmisartan/Hydrochlorothi

80 mg/25

Kingdom

Limited

hydrochlorothiazide

azide 80mg/25mg Tablets

mg

irbesartan

Irbesartan 75mg Film-

75 mg

6 Riverview Road, Beverley


East Yorkshire HU17 0LD
United Kingdom
United

Fair-Med Healthcare GmbH

Kingdom

Planckstrasse 13

coated Tablets

tablet

DE-22765 Hamburg
Germany
United

Fair-Med Healthcare GmbH

Kingdom

Planckstrasse 13

irbesartan

Irbesartan 150mg Film-

150 mg

coated Tablets

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany
United

Fair-Med Healthcare GmbH

Kingdom

Planckstrasse 13

irbesartan

Irbesartan 300mg Film-

300 mg

coated Tablets

Film - coated

Oral use

tablet

DE-22765 Hamburg
Germany
United

Fair-Med Healthcare GmbH

Irbesartan/hydroch

Irbesartan/Hydrochlorothia

150

Film - coated

Kingdom

Planckstrasse 13

lorothiazide

zide 150mg/12.5mg film-

mg/12,5

tablet

coated tablets

mg

DE-22765 Hamburg

Oral use

Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

United

Fair-Med Healthcare GmbH

Irbesartan/hydroch

Irbesartan/Hydrochlorothia

Kingdom

Planckstrasse 13

lorothiazide

INN

DE-22765 Hamburg

Pharmaceutical

Route of

Form

administration

300

Film - coated

Oral use

zide 300mg/12.5mg film-

mg/12,5

tablet

coated tablets

mg

Invented name

Strength

Germany
United

Fair-Med Healthcare GmbH

Irbesartan/hydroch

Irbesartan/Hydrochlorothia

300 mg/25

Film - coated

Kingdom

Planckstrasse 13

lorothiazide

zide 300mg/25mg film-

mg

tablet

DE-22765 Hamburg

Oral use

coated tablets

Germany
United

Fannin (UK) Ltd

Kingdom

42-46 Booth Drive

Fluconazole

Fluconazole 150mg capsule

150 mg

Capsule, hard

Oral use

Fexofenadine

Fexofenadine 120mg film-

120 mg

Film - coated

Oral use

Park Farm South


Wellingborough
Northamptonshire NN8 6GT
United Kingdom
United

Fannin (UK) Ltd

Kingdom

42-46 Booth Drive

coated tablets

tablet

Park Farm South


Wellingborough
Northamptonshire NN8 6GT
United Kingdom
United

Fannin (UK) Ltd

Kingdom

42-46 Booth Drive

Fexofenadine

Fexofenadine 180mg filmcoated tablets

180 mg

Film - coated

Oral use

tablet

Park Farm South


Wellingborough
Northamptonshire NN8 6GT
United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

United

FDC Pharma

Kingdom

Unit 6, Fulcrum 1, Solent Way

INN

Invented name

Strength

Pharmaceutical

Route of

Form

administration

Amlodipine

Amlodipine 5mg Tablets

5 mg

Tablet

Oral use

Amlodipine

Amlodipine 10mg Tablets

10 mg

Tablet

Oral use

Repaglinide

Repaglinide Mylan 0.5mg

0,5 mg

Tablet

Oral use

1 mg

Tablet

Oral use

2 mg

Tablet

Oral use

5 mg

Orodispersible

Oral use

Whiteley, Fareham
Hampshire PO15 7FE
United Kingdom
United

FDC Pharma

Kingdom

Unit 6, Fulcrum 1, Solent Way


Whiteley, Fareham
Hampshire PO15 7FE
United Kingdom

United

Generics (UK) Ltd

Kingdom

Station Close, Potters Bar

Tablets

Hertfordshire, EN6 1TL


United Kingdom
United

Generics (UK) Ltd

Kingdom

Station Close, Potters Bar

Repaglinide

Repaglinide Mylan 1mg


Tablets

Hertfordshire, EN6 1TL


United Kingdom
United

Generics (UK) Ltd

Kingdom

Station Close, Potters Bar

Repaglinide

Repaglinide Mylan 2mg


Tablets

Hertfordshire, EN6 1TL


United Kingdom
United

Generics (UK) Ltd

Donepezil

Donepezil Hydrochloride

Kingdom

Station Close, Potters Bar

hydrochloride

5mg Orodispersible Tables

tablet

Hertfordshire, EN6 1TL


United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

United

Generics (UK) Ltd

Donepezil

Donepezil Hydrochloride

Kingdom

Station Close, Potters Bar

hydrochloride

10mg Orodispersible

INN

Hertfordshire, EN6 1TL

Invented name

Strength

10 mg

Pharmaceutical

Route of

Form

administration

Orodispersible

Oral use

tablet

Tables

United Kingdom
United

Generics (UK) Ltd

Rizatriptan

Rizatriptan 10mg

Kingdom

Station Close, Potters Bar

benzoate

Orodispersible Tablet

Esomeprazole 20mg

10 mg

Orodispersible

Oral use

tablet

Hertfordshire, EN6 1TL


United Kingdom
United

Generics (UK) Ltd

Esomeprazole

Kingdom

Station Close, Potters Bar

magnesium

Hertfordshire, EN6 1TL

20 mg

Gastro-resistant Capsules,

Gastro - resistant

Oral use

capsule

hard

United Kingdom
United

Generics (UK) Ltd

Esomeprazole

Esomeprazole 40mg

Kingdom

Station Close, Potters Bar

magnesium

Gastro-resistant Capsules,

Hertfordshire, EN6 1TL

40 mg

Gastro - resistant

Oral use

capsule

hard

United Kingdom
United

Generics (UK) Ltd

Levodopa/carbidop

Levodopa/Carbidopa/Entac

150

Film - coated

Kingdom

Station Close, Potters Bar

a/entacapone

apone film-coated tablets

mg/37,5

tablet

150/37.5/200mg

mg/200 mg

Pantoprazole 20mg Gastro-

20 mg

Hertfordshire, EN6 1TL

Oral use

United Kingdom
United

Lupin (Europe) Limited

Kingdom

Victoria Court, Bexton Road

Pantoprazole

Resistant tablets

Gastro - resistant

Oral use

tablet

Knutsford, Cheshire WA16


0PF
United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

United

Lupin (Europe) Limited

Kingdom

Victoria Court, Bexton Road

INN

Pantoprazole

Invented name

Pantoprazole 40mg Gastro-

Strength

40 mg

Resistant tablets

Pharmaceutical

Route of

Form

administration

Gastro - resistant

Oral use

tablet

Knutsford, Cheshire WA16


0PF
United Kingdom
United

Morningside Healthcare

Phenoxymethyl

Phenoxymethylpenicillin

Kingdom

Limited

penicillin

250mg Film-coated Tablets

250 mg

Film - coated

Oral use

tablet

115 Narborough Road


Leicester, LE3 0PA
United Kingdom
United

Morningside Healthcare

Metformin

Bolamyn/Metabet SR

Kingdom

Limited

hydrochloride

1000mg Prolonged Release

115 Narborough Road

1000 mg

Prolonged -

Oral use

release tablet

Tablets

Leicester, LE3 0PA


United Kingdom
United

Niche Generics Limited

Kingdom

1 The Cam Centre

irbesartan

Irbesartan Niche 150mg

150 mg

film-coated tablets

Film - coated

Oral use

tablet

Wilbury Way, Hitchin


Hertfordshire SG4 0TW
United Kingdom
United

Niche Generics Limited

Kingdom

1 The Cam Centre

irbesartan

Irbesartan Niche 150mg


film-coated tablets

150 mg

Film - coated

Oral use

tablet

Wilbury Way, Hitchin


Hertfordshire SG4 0TW
United Kingdom

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Member State

Marketing Authorisation

(in EEA)

Holder

United

Ranbaxy UK Ltd.

Kingdom

Building 4, Chiswick Park

INN

Alendronic acid

Invented name

Alendronic Acid 70mg

Strength

70 mg

Pharmaceutical

Route of

Form

administration

Tablet

Oral use

Oral use

Tablets

566 Chiswick High Road


London, W4 5YE
Untied Kingdom
United

Torrent Pharma GmbH

Irbesartan/hydroch

Irbesartan

150

Film - coated

Kingdom

Sdwestpark 50

lorothiazide

Hydrochlorothiazide

mg/12,5

tablet

90449 Nrnberg

150mg/12.5mg Film-

mg

Germany

coated tablets

United

Torrent Pharma GmbH

Irbesartan/hydroch

Irbesartan

300

Film - coated

Kingdom

Sdwestpark 50

lorothiazide

Hydrochlorothiazide

mg/12,5

tablet

90449 Nrnberg

300mg/12.5mg Film-

mg

Germany

coated tablets

United

Torrent Pharma GmbH

Irbesartan/hydroch

Irbesartan

300 mg/25

Film - coated

Kingdom

Sdwestpark 50

lorothiazide

Hydrochlorothiazide

mg

tablet

75 mg

Film - coated

90449 Nrnberg
Torrent Pharma GmbH

Kingdom

Sdwestpark 50

Oral use

300mg/25mg Film-coated

Germany
United

Oral use

tablets
irbesartan

Irbesartan 75mg Filmcoated tablets

Oral use

tablet

90449 Nrnberg
Germany
United

Torrent Pharma GmbH

Kingdom

Sdwestpark 50

irbesartan

Irbesartan 150mg Filmcoated tablets

150 mg

Film - coated

Oral use

tablet

90449 Nrnberg
Germany

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
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Member State

Marketing Authorisation

(in EEA)

Holder

United

Torrent Pharma GmbH

Kingdom

Sdwestpark 50

INN

irbesartan

Invented name

Irbesartan 300mg Film-

Strength

300 mg

coated tablets

Pharmaceutical

Route of

Form

administration

Film - coated

Oral use

tablet

90449 Nrnberg
Germany
United

Waymade PLC

Venlafaxine

Venlasov XL 75mg Modified

Kingdom

Sovereign House

hydrochloride

Release Capsules

75 mg

Prolonged -

Oral use

release capsule,

Miles Grat Road, Basildon

hard

Essex SS14 3FR


United Kingdom
United

Waymade PLC

Venlafaxine

Venlasov XL 150mg

Kingdom

Sovereign House

hydrochloride

Modified Release Capsules

150 mg

Prolonged -

Oral use

release capsule,

Miles Grat Road, Basildon

hard

Essex SS14 3FR


United Kingdom
United

Wockhardt UK Limited

Kingdom

Ash Road North

Clopidogrel

Clopidogrel 75mg Film-

75 mg

coated Tablets

Film - coated

Oral use

tablet

Wrexham Industrial Estate


Wrexham LL13 9UF
United Kingdom
United

YJBPort Limited

Kingdom

74 Briarwood Drive

Hydrocortisone

Hydrocortisone 10mg

10 mg

Tablet

Oral use

Tablets

Northwood Hills
Middlesex HA6 1PL
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 130/131

Member State

Marketing Authorisation

(in EEA)

Holder

United

YJBPort Limited

Kingdom

74 Briarwood Drive

INN

Hydrocortisone

Invented name

Hydrocortisone 20mg

Strength

20 mg

Pharmaceutical

Route of

Form

administration

Tablet

Oral use

Tablets

Northwood Hills
Middlesex HA6 1PL
United Kingdom

GVK Bio - Products for which the marketing authorisations are recommended for suspension Rev. 1
EMA/52196/2015

Page 131/131