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: Amlodipine
Active Ingredient: Amlodipine besilate 6.93mg equivalent to Amlodipine 5mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cadila Pharmaceuticals Limited, Gujarat State, India
Product: Amlodipine
Active Ingredient: Amlodipine besilate 13.87mg equivalent to Amlodipine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cadila Pharmaceuticals Limited, Gujarat State, India
Product: Hypocart
Active Ingredients: Candesartan cilexetil 8mg
Hydrochlorothiazide 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Siegfried Limited, Zofingen, Switzerland
Product: Hypocart
Active Ingredients: Candesartan cilexetil 16mg
Hydrochlorothiazide 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Siegfried Limited, Zofingen, Switzerland
Product: Meropenem Sandoz
Active Ingredient: Meropenem trihydrate 570.78mg equivalent to Meropenem 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Private Limited, Maharashtra, India
Product: Meropenem Sandoz
Active Ingredient: Meropenem trihydrate 1.14155g equivalent to Meropenem 1mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Private Limited, Maharashtra, India
Product: Nauzene
Active Ingredient: Cyclizine hydrochloride 50mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Tamil Nadur, India
Product: Your Pharmacy Ibuprofen Suspension
Active Ingredient: Ibuprofen 20mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Product: Your Pharmacy Paracetamol (General Sale)
Active Ingredient: Paracetamol 500mg
Dosage Form: Coated tablet
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Product: Your Pharmacy Paracetamol (Pharmacy Only)
Active Ingredient: Paracetamol 500mg
Dosage Form: Coated tablet
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Dated this 16th day of November 2011.
DR DON MACKIE, 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).