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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Bendroflumethiazide
Active Ingredient: Bendroflumethiazide 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: Cozaar
Active Ingredient: Losartan potassium 12.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme UK Limited, Northumberland, United Kingdom
Product: Cozaar
Active Ingredient: Losartan potassium 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme UK Limited, Northumberland, United Kingdom
Product: Cozaar
Active Ingredient: Losartan potassium 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme UK Limited, Northumberland, United Kingdom
Product: Cozaar
Active Ingredient: Losartan potassium 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme UK Limited, Northumberland, United Kingdom
Product: I-Bendroflumethiazide
Active Ingredient: Bendroflumethiazide 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: Panadeine
Active Ingredients: Codeine phosphate hemihydrate 8mg
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Australia Pty Limited, Dandenong, Australia
GlaxoSmithKline Australia Pty Limited, Ermington, Australia
Product: Panadeine Caplets
Active Ingredients: Codeine phosphate hemihydrate 8mg
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Australia Pty Limited, Dandenong, Australia
GlaxoSmithKline Australia Pty Limited, Ermington, Australia
Product: Panadeine Extra
Active Ingredients: Codeine phosphate hemihydrate 15mg
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Ermington, Australia
Product: Pregnyl
Active Ingredient: Chorionic gonadotrophin 1500IU
Dosage Form: Powder for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: NV Organon, Oss, The Netherlands
Product: Pregnyl
Active Ingredient: Chorionic gonadotrophin 5000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: NV Organon, Oss, The Netherlands
Dated this 6th day of October 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).