Healthcare professionals are encouraged to report all serious andnon-serious suspected adverse drug reactions to new drugs. Youractive participation in the adverse drug reaction monitoringprogramme will provide valuable support to the ongoing post-marketing surveillance on drug safety.

Healthcare professionals are encouraged to report all serious andnon-serious suspected adverse drug reactions to new drugs. Youractive participation in the adverse drug reaction monitoringprogramme will provide valuable support to the ongoing post-marketing surveillance on drug safety.

How to report:The ADR and Vaccine Adverse Event (VAE) reporting forms can be obtained athttp://www.hsa.gov.sg/ae_online, from medical clinics, pharmacies, hospitals/healthinstitutions or the Vigilance Branch of HSA. Online reporting is also available at thesame website. Please send the completed forms to HSA either by post, email or fax tothe Vigilance Branch.

Where to send your report:Vigilance BranchHealth Products Regulation GroupHealth Sciences Authority11 Biopolis Way #11-03 HeliosSingapore 138667Tel : +65- 6866 3538Fax : +65- 6478 9069Email : HSA_productsafety@hsa.gov.sg

NEW DRUGSAPPROVED IN 2009

NEW DRUGSAPPROVED IN 2009

POM: Prescription only medicine P: Pharmacy-only medicine GSL: General Sales List

New chemical / biological entity Pharmacotherapeutic group

Agalsidase beta 35mg α-galactosidase A enzymeFabrazyme® powder for solution (POM)for injectionDabigatran 75mg Antithrombotic agent (POM)Pradaxa® hard capsuleDoripenem 500mg Antibiotic (POM)Doribax® powder for injectionEtravirine 100mg Antiviral agent (POM)Intelence® tabletH1N1 Pandemic Influenza A (2009) virus Pandemic vaccine (POM)Pandemrix® H1N1 injectionH1N1 Pandemic Influenza A (2009) virus Pandemic vaccine (POM)Panvax® H1N1 Vaccine/Panvax® H1N1Vaccine JuniorHydromorphone 32mg Opioid analgesic (POM)Jurnista® prolonged release tablet*Hydroquinone 4% w/w Dermatological agent (POM)Eldopaque Forte® cream,Eldoquin Forte® creamH5N1 Influenza virus Pandemic vaccine (POM)Prepandrix® injectionIxabepilone 45mg Antineoplastic agent (POM)Ixempra® for injectionLanthanum 250mg Agent for treatment ofFosrenol® chewable tablet hyperphosphataemia (POM)Lenalidomide 5mg Antineoplastic agent (POM)Revlimid® capsuleMaraviroc 150mg Antiviral (POM)Celsentri® film-coated tabletNiacin, Laropiprant 1gm/20mg Lipid Modifying agent (POM)Tredaptive® tabletRetapamulin 1% w/w Topical antibiotic (POM)Altargo® ointmentSevelamer 800mg Agent for treatment ofRenvela® tablet hyperphosphataemia (POM)Solifenacin 5mg Urinary antispasmodic agentVesicare® tablet (POM)Tamsulosin 400mcg Agent used in benignHarnal OCAS® prolonged release prostatic hypertrophy (POM)film-coated tabletTegafur, Oteracil, Gimeracil Antineoplastic agent (POM)20mg/19.6mg/5.8mgTS-ONE® capsuleTemsirolimus 25 mg/ml Antineoplastic agent (POM)Torisel® concentrate for injectionTocilizumab 20 mg/ml Immunosuppressant (POM)Actemra® concentrate for solutionfor infusionTrabectedin 1mg Antineoplastic agent (POM)Yondelis® powder for injectionUstekinumab 45mg/0.5 ml Immunosuppressant (POM)Stelara® solution for injectionVaccinia virus,ACAM2000® injection, Pandemic vaccine (POM)powder, lyophilized, for solution*Previously regulated as a cosmetic product

New combination Pharmacotherapeutic group

Aliskiren 150mg, Hydrochlorothiazide 12.5 mg Antihypertensive agent (POM)Rasilez HCT® tabletBromhexine 0.8mg/ml, Cough & cold preparation (P)pseudoephedrine 4mg/mlDuro-Tuss® chesty cough liquidplus nasal decongestantBenzydamine 3mg, Locally acting oral anti-Cetylpyridinium 1.33mg, inflammatory and anti-bacterialDifflam® eucalyptus & menthol agent (P)sugar free lozenges

Benzydamine 1.5mg, Cetylpyridinium 1.33mg, Locally acting oral anti-Pholcodine 5.5mg inflammatory, anti-bacterialDifflam® blackcurrant sugar free cough lozenges agent and cough suppressant (P)Calcium carbonate 160mg, Agent for gastro-oesophagealSodium alginate 500mg, reflux disease (GSL)Sodium bicarbonate 267mg per tablet/per mlGaviscon® extra strength 500 pepperminttablets, Gaviscon® liquid sachetsHepatitis A virus, Bacterial & viral vaccines (POM)Salmonella typhi Vi polysaccharideVivaxim® vaccineTimolol 5mg/ml, Travoprost 40ug/ml Antiglaucoma preparation (POM)DuoTrav® eye drops, solutionMeasles, mumps, rubella, varicella viruses Viral vaccines (POM)Priorix-Tetra® injection, powder,lyophilized, for solutionVildagliptin 50mg, metformin 850mg Anti-diabetic agent (POM)Galvusmet® tablet

New formulation Pharmacotherapeutic group

Antithrombin III, human 500 iu/10 ml Antithrombotic agent (POM)Anbinex® powder for injection*Budesonide 200mcg/dose Corticosteroid (POM)Pulmicort® HFA pressurised metereddose inhalerCiprofloxacin 500mg Antibiotic (POM)Cipro XR® film-coated tabletFenofibrate 145mg Lipid modifying agent (POM)Lipanthyl penta® film coated tabletFluticasone furoate 27.5mcg/sprayAvamys® nasal spray Corticosteroid (POM)*CFC-free formulation

New dosage form Pharmacotherapeutic group

Benzydamine 1.5mg/ml Locally acting oral anti-Difflam® anti-inflammatory throat spray inflammatory agent (P)Escitalopram 20mg/ml Antidepressant (POM)Lexapro® oral dropsInsulin lispro 100iu/ml Insulin analogue (POM)Humalog® pen solution for injectionLevetiracetam 100mg/ml Antiepileptic agent (POM)Keppra® concentrate for solutionfor infusionMannitol 0mg, 5mg, 10mg, 20mg, 40mg Diagnostic agent (POM)Aridol® mannitol powder for inhalationcomposite packOxycodone 10 mg/ml Opioid analgesic (POM)OxyNorm® sterile solution forinjection or infusionRotavirus, (human) Viral vaccine (POM)Rotarix® oral suspensionSodium hyaluronate 30mg/ml Ophthalmological agent (POM)Healon D® solution for intraocularapplicationTopotecan 0.25mg, 1mg Antineoplastic agent (POM)Hycamtin® hard capsules

Biosimilar Pharmacotherapeutic group

Somatropin Growth hormone (POM)Scitropin A® powder for solution& injection 1.3mg/ml (4IU) &5mg/ml (15IU), solution for injection5mg/1.5ml (15IU) & 10mg/1.5ml (30IU)

Drug_List _poster_2009.p65 4/10/2010, 3:17 PM1