Notice Type
Departmental
Notice Title

Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the schedule hereto:
Schedule
Product: Apo-Captopril
Active Ingredient(s): Captopril 12.5mg
Dosage Form: Tablet
NZ Sponsor: Apotex (NZ) Limited
Manufacturer(s): Apotex Inc., Weston, Ontario, Canada
Product: Apo-Captopril
Active Ingredient(s): Captopril 25mg
Dosage Form: Tablet
NZ Sponsor: Apotex (NZ) Limited
Manufacturer(s): Apotex Inc., Weston, Ontario, Canada
Product: Apo-Captopril
Active Ingredient(s): Captopril 50mg
Dosage Form: Tablet
NZ Sponsor: Apotex (NZ) Limited
Manufacturer(s): Apotex Inc., Weston, Ontario, Canada
Product: Cilicaine VK 250
Active Ingredient(s): Phenoxymethylpenicillin potassium 277.18mg equivalent to 250mg phenoxymethyl penicillin
Dosage Form: Capsule
NZ Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Sigma Pharmaceuticals Pty Limited, Croydon, Victoria, Australia
Product: Cilicaine VK 500
Active Ingredient(s): Phenoxymethylpenicillin potassium 544.37mg equivalent to 500mg phenoxymethyl penicillin
Dosage Form: Capsule
NZ Sponsor: Pharmaco (NZ) Limited
Manufacturer(s): Sigma Pharmaceuticals Pty Limited, Croydon, Victoria, Australia
Product: Nifehexal
Active Ingredient(s): Nifedipine 20mg
Dosage Form: Modified release tablet
NZ Sponsor: Hexal New Zealand Limited
Manufacturer(s): Rottendorf Pharma Pty Limited, Enningerloh, Germany
Product: Rubifen
Active Ingredient(s): Methylphenidate hydrochloride 10mg
Dosage Form: Tablet
NZ Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): Laboratorios Rubio SA., Poligono Industrial Comte deSert, Castellbisbal, Barcelona, Spain
Dated this 8th day of March 2000
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).