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: AFT - Metoprolol CR
Active Ingredient: Metoprolol succinate 23.75mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Sofarimex Industria Quimica e Farmaceutica Lda, Agualva, Cacem, Portugal
Product: AFT - Metoprolol CR
Active Ingredient: Metoprolol succinate 47.5mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Sofarimex Industria Quimica e Farmaceutica Lda, Agualva, Cacem, Portugal
Product: AFT - Metoprolol CR
Active Ingredient: Metoprolol succinate 95mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Sofarimex Industria Quimica e Farmaceutica Lda, Agualva, Cacem, Portugal
Product: AFT - Metoprolol CR
Active Ingredient: Metoprolol succinate 190mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Sofarimex Industria Quimica e Farmaceutica Lda, Agualva, Cacem, Portugal
Product: Paracetamol Classic
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Paracetamol
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Polio Sabin (Oral) Multidose
Active Ingredients: Polio virus type 1 1,000,000CCID50
Polio virus type 2 100,000CCID50
Polio virus type 3 630,957CCID50
Dosage Form: Oral suspension
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Parc de la Noire Epine, Wavre, Belgium
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
Dated this 1st day of August 2008.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).