Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Concentrated Haemodialysis Solution - AC-F 2155G Part A
Active Ingredients: Acetic acid 8.4g/L
Calcium chloride dihydrate 7.7g/L
Glucose 34.7g/L
Magnesium chloride 3.6g/L
Potassium chloride 5.2g/L
Sodium chloride 214.8g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care Australia Pty Limited (NZ)
Manufacturer: Fresenius Medical Care Australia Pty Limited, Smithfield, Australia
Product: Flucasten 150mg capsule
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Fluconazole 150mg capsule
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: I-Fluconazole 150mg capsule
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Lamivudine Alphapharm
Active Ingredient: Lamivudine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Product: Lamivudine Alphapharm
Active Ingredient: Lamivudine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Product: Mylan Midazolam
Active Ingredient: Midazolam 1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Cenexi SAS, Fontenay-sous-Bois, France
Product: Mylan Midazolam
Active Ingredient: Midazolam 5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Cenexi SAS, Fontenay-sous-Bois, France
Product: Paracare Sore Throat Relief
Active Ingredient: Paracetamol 4.167%w/w
Dosage Form: Oral suspension
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Product: Propofol Pfizer
Active Ingredient: Propofol 10mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Claris Life Sciences Limited, Gujarat, India
Product: Riamet Dispersible
Active Ingredients: Artemether 20mg
Lumefantrine 120mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharmaceuticals Corporation, New York, United States of America
Dated this 12th day of May 2011.
PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).