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: AS-Pemetrexed
Active Ingredient: Pemetrexed disodium hemipentahydrate 604.12mg equivalent to pemetrexed 500mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: GN-Pemetrexed
Active Ingredient: Pemetrexed disodium hemipentahydrate 604.12mg equivalent to pemetrexed 500mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Mylan-Bosentan
Active Ingredient: Bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Mylan-Bosentan
Active Ingredient: Bosentan monohydrate 129.082mg equivalent to bosentan anhydrous 125mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Pemetrexed-PF
Active Ingredient: Pemetrexed disodium hemipentahydrate 604.12mg equivalent to pemetrexed 500mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: Perjeta
Active Ingredient: Pertuzumab 420mg equivalent to 30mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Topicil
Active Ingredient: Clindamycin hydrochloride 162.87mg equivalent to clindamycin 150mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
Dated this 11th day of July 2013.
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).