Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand
of the new medicines set out in the Schedule hereto:
Schedule
Product: Gemcitabine Ebewe
Active Ingredient: Gemcitabine hydrochloride 1140mg equivalent to 1000mg gemcitabine
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Gemcitabine Ebewe
Active Ingredient: Gemcitabine hydrochloride 228mg equivalent to 200mg gemcitabine
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Irinotecan Ebewe
Active Ingredient: Irinotecan hydrochloride trihydrate 20mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Product: Lora-Tabs Allergy & Hayfever
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bangalore, India
Product: Panadol Cold & Flu Hot Lemon & Honey
Active Ingredient: Paracetamol 600mg
Dosage Form: Powder for oral solution
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham SA, Madrid, Spain
Product: Sebivo
Active Ingredient: Telbivudine 20mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma SAS, Huningue, France
Product: Voltaren Rapid 12.5 Soft Caps
Active Ingredient: Diclofenac potassium 12.5mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: R P Scherer GmbH & Co KG, Baden, Germany
Product: Voltaren Rapid 25 Soft Caps
Active Ingredient: Diclofenac potassium 25mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: R P Scherer GmbH & Co KG, Baden, Germany
Dated this 24th day of February 2010.
ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).