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C 78/20 EN Official Journal of the European Union 31.3.

2006

Summary of Community decisions on marketing authorizations in respect of medicinal products


from 1 February 2006 to 28 February 2006
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2006/C 78/04)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the Holder(s) of the Date of


Name(s) of the medicinal product Member State concerned
decision marketing authorization notification

21.2.2006 Lanzoprazol ratiopharm See Annex I See Annex I 23.2.2006

21.2.2006 Lansoprazol ABZ-Pharma See Annex II See Annex II 23.2.2006

21.2.2006 Lansoprazol CT-Arzneimittel See Annex III See Annex III 23.2.2006

(1) OJ L 311, 28.11.2001, p. 67.


(2) OJ L 311, 28.11.2001, p. 1.
31.3.2006 EN Official Journal of the European Union C 78/21

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member Marketing Authorisation Route of


Applicant Invented name Strength Pharmaceutical Form
State Holder administration

Austria — ratiopharm Arznei- Lansoprazol ‘ratiopharm’ 15 mg Gastro-resistant Oral use


mittel Vertriebs-GmbH 15 mg Kapseln capsule, hard
Albert-Schweitzer-G. 3
A-1140 Wien Lansoprazol ‘ratiopharm’ 30 mg Gastro-resistant Oral use
30 mg Kapseln capsule, hard

Belgium — ratiopharm Belgium Lansoprazol-ratiopharm 15 mg Gastro-resistant Oral use


Rue Saint-Lambert 14 15 mg gelules gastro-résis- capsule, hard
B-1120 Bruxelles/ tante
Brussel
Lansoprazol-ratiopharm 30 mg Gastro-resistant Oral use
30 mg gelules gastro-résis- capsule, hard
tante

Denmark — ratiopharm GmbH Lantrolix 15 mg entero- 15 mg Gastro-resistant Oral use


Graf-Arco-Straße 3 kapsler, hårde capsule, hard
D-89079 Ulm
Lantrolix 30 mg entero- 30 mg Gastro-resistant Oral use
kapsler, hårde capsule, hard

Finland ratiopharm GmbH — Lansoprazol ratiopharm 15 mg Gastro-resistant Oral use


Graf-Arco-Straße 3 15 mg capsule, hard
D-89079 Ulm
Lansoprazol ratiopharm 30 mg Gastro-resistant Oral use
30 mg capsule, hard

Germany — ratiopharm GmbH Lansoprazol-ratiopharm 15 mg Gastro-resistant Oral use


Graf-Arco-Straße 3 15 mg Hartkapseln capsule, hard
D-89079 Ulm
Lansoprazol-ratiopharm 30 mg Gastro-resistant Oral use
30 mg Hartkapseln capsule, hard

Italy — ratiopharm GmbH Lansoprazolo ratiopharm 15 mg Gastro-resistant Oral use


Graf-Arco-Straße 3 15 mg capsule di gelatina capsule, hard
D-89079 Ulm dura

Lansoprazolo ratiopharm 30 mg Gastro-resistant Oral use


30 mg capsule di gelatina capsule, hard
dura

Luxem- — ratiopharm GmbH Lansoprazol-ratiopharm 15 mg Gastro-resistant Oral use


bourg Graf-Arco-Straße 3 15 mg Hartkapseln capsule, hard
D-89079 Ulm
Lansoprazol-ratiopharm 30 mg Gastro-resistant Oral use
30 mg Hartkapseln capsule, hard

Portugal — ratiopharm Lda, Lansoprazol ratiopharm 15 mg Gastro-resistant Oral use


Portugal 15 mg cápsulas gastro- capsule, hard
Edifício Tejo, 6.o piso resistentes
Rua Quinta do
Pinheiro Lansoprazol ratiopharm 30 mg Gastro-resistant Oral use
P-2790-143 Carnaxide 30 mg cápsulas gastro- capsule, hard
resistentes

Sweden — ratiopharm GmbH Sopranix 15 mg, entero- 15 mg Gastro-resistant Oral use


Graf-Arco-Straße 3 kapsler, hårda capsule, hard
D-89079 Ulm
Sopranix 30 mg, entero- 30 mg Gastro-resistant Oral use
kapsler, hårda capsule, hard
C 78/22 EN Official Journal of the European Union 31.3.2006

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member Marketing Authorisation Route of


Applicant Invented name Strength Pharmaceutical Form
State Holder administration

Finland ratiopharm GmbH — Lansoprazol AbZ-Pharma 15 mg Gastro-resistant Oral use


Graf-Arco-Str. 3 15 mg capsule, hard
D-89075 Ulm
Lansoprazol AbZ-Pharma 30 mg Gastro-resistant Oral use
30 mg capsule, hard

Germany — ratiopharm GmbH Lansoprazol AbZ 15 mg 15 mg Gastro-resistant Oral use


Graf-Arco-Str. 3 Hartkapseln capsule, hard
D-89075 Ulm
Lansoprazol AbZ 30 mg 30 mg Gastro-resistant Oral use
Hartkapseln capsule, hard

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member Marketing Authorisation Route of


Applicant Invented name Strength Pharmaceutical Form
State Holder administration

Finland ratiopharm GmbH — Lansoprazol CT-Arznei- 15 mg Gastro-resistant Oral use


Graf-Arco-Straße 3 mittel 15 mg capsule, hard
D-89079 Ulm
Lansoprazol CT-Arznei- 30 mg Gastro-resistant Oral use
mittel 30 mg capsule, hard

Germany — ratiopharm GmbH Lansoprazol-CT 15 mg 15 mg Gastro-resistant Oral use


Graf-Arco-Straße 3 Hartkapseln capsule, hard
D-89079 Ulm
Lansoprazol-CT 30 mg 30 mg Gastro-resistant Oral use
Hartkapseln capsule, hard