NEW DRUGS

APPROVED IN 2008
Healthcare professionals are encouraged to report all serious and non-serious
suspected adverse drug reactions to new drugs. Your active participation in the
adverse drug reaction monitoring programme will provide valuable support to
the ongoing post-marketing surveillance on drug safety.
POM: Prescription only medicine GSL: General Sales List
Drugs are listed under the pharmacotherapeutic groups as
defined by the Anatomical Therapeutic Chemical (ATC)
classification produced by the WHO Collaborating Centre
for Drug Statistics Methodology.
How t o report :
The ADR reporting form can be obtained at
ht t p://www.hsa.gov.sg/adr_f orm, from medical clinics,
pharmacies, hospitals/health institutions or
Pharmacovigilance (PV) Branch of the HSA.
Please send the completed ADR reporting form either by mail,
email or fax to the PV Branch. Online ADR reporting is available
at ht t p://www.hsa.gov.sg/adr_online
Where t o send your report :
Pharmacovigilance Branch
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way #11-03 Helios
Singapore 138667
Tel : +65- 6866 3538
Fax : +65- 6478 9069
Email : HSA_drugsafety@hsa.gov.sg
New chemical /biological ent it y Pharmacot herapeut ic group
Abatacept 250mg Immunosuppressants (POM )
Orencia injection
Alglucosidase alfa 50mg Enzymes (POM )
M yozyme powder for solution
for infusion
Aliskiren 150mg, 300mg Agents acting on the
Rasilez film coated tablet renin-angiotensin system (POM )
Anidulafungin 100mg Antimycotics for systemic use
Eraxis injection (POM )
Daptomycin 500mg Antibacterials for systemic use
Cubicin injection (POM )
Darunavir 300mg Protease inhibitors (POM )
Prezista tablet
Deferasirox 125mg, 250mg, 500mg Iron chelating agents (POM )
Exjade dispersible tablet
Exenatide 5mcg, 10mcg Blood glucose lowering drugs
Byetta solution for injection (POM )
Human Anti-D immunoglobulin Immunoglobulins (POM )
600IU (120mcg), 1500IU (300mcg),
5000IU (1000mcg)
Winrho SDF injection
M ethoxy polyethylene glycol-epoetin Antianaemic preparations (POM )
beta 1000mcg/ml, 100mcg/ml,
200mcg/ml, 300mcg/ml, 50mcg/ml,
100mcg/0.3ml, 150mcg/0.3ml,
200mcg/0.3ml, 250mcg/0.3ml,
50mcg/0.3ml, 75mcg/0.3ml,
800mcg/0.6ml
M ircera solution for injection vial &
pre-filled syringe
M ethyl 5-aminolevulinate Antineoplastic agents (POM )
hydrochloride 20% w/w
M etvix cream
Nilotinib 200mg Antineoplastic agents (POM )
Tasigna capsule
Purified tetanus toxoid Bacterial vaccines (POM )
(= 40IU/ 0.5ml dose)
Tetavax Vaccine
Raltegravir 400mg Antivirals for systemic use
Isentress tablet (POM )
Ranibizumab 3mg/0.3ml Ocular vascular disorder agents
Lucentis solution for injection (POM )
Recombinant antihaemophilic Antihaemorrhagics (POM )
factor VIII octocog Alfa 250IU,
500IU, 1000IU, 1500 IU
Advate powder and solvent
for solution for injection
Rivaroxaban micronized 10mg Antithrombotic agents (POM )
Xarelto film coated tablet
Varicella-zoster virus, live attenuated Viral vaccines (POM )
Oka/M erck strain 19, 400 PFU
Zostavax injection (frozen and
refrigerator stable formulation)
Vildagliptin 50mg Blood glucose lowering drugs
Galvus tablet (POM )
New combinat ion Pharmacot herapeut ic group
Amlodipine, valsartan Agents acting on the
5/80, 5/160, 10/160mg renin-angiotensin system (POM )
Exforge film-coated tablet
Brimonidine (2mg/ml), timolol (5mg/ml) Antiglaucoma preparations and
Combigan ophthalmic solution miotics (POM )
Glimepiride, rosiglitazone 1/4, Combinations of oral blood
2/4, 4/4mg glucose lowering drugs (POM )
Avandaryl tablet
Losartan 100mg, Angiotensin II antagonists &
hydrochlorothiazide 12.5mg diuretics (POM )
Hyzaar Plus tablet
M etformin, sitagliptin Combinations of oral blood
500/50, 850/50, 1000/50mg glucose lowering drugs (POM )
Janumet tablet
New f ormulat ion Pharmacot herapeut ic group
Azithromycin 2g M acrolides (POM )
Zmax granule for suspension,
extended release
M easles, mumps, rubella, varicella Viral vaccines (POM )
viruses ProQuad refridgerator stable
formulation
M esalazine 1g/satchet Intestinal anti-inflammatory
Pentasa prolonged release granules (POM )
Omeprazole 20mg Proton pump inhibitors (POM )
Losec capsules, enteric coated pellets
Quetiapine 50mg, 200mg, 300mg, Antipsychotics (POM )
400mg
Seroquel XR tablet
Terbinafine 1% (10mg/g) Antifungals for topical use (GSL)
Lamisil Once film forming solution
New dosage f orm Pharmacot herapeut ic group
Fluocinolone 0.59mg Anti-inflammatory agents
Retisert intravitreal implant (POM )
Ibandronic acid 50mg Bisphosphonates (POM )
Bondronate tablet
Levocetirizine 5mg/ml Antihistamines (POM )
Xyzal oral drops
Rivastigmine 9mg/5cm
2
, 18mg/10cm
2
Anti-dementia drugs (POM )
Exelon transdermal patch
Ot hers Pharmacot herapeut ic group
Glucagon 1mg/ml Pancreatic hormones (POM )
Glucagen hypokit for injection
Hepatitis B immune globulin (human) Immune sera &
0.5ml, 1ml immunoglobulins (POM )
HyperHEP B S/D pre-filled syringe
Influenza virusA & B Influenza vaccines (POM )
FluLaval suspension for injection
Insulin glargine 100IU/ml Insulins & analogues (POM )
Lantus SoloStar solution for
injection in a pre-filled pen
Insulin glulisine 100units/ml Insulins & analogues (POM )
Apidra SoloStar solution for
injection in a pre-filled pen
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