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: Postrelle
Active Ingredient: Levonorgestrel 1.5mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Famy Care Limited, Ahmedabad, India
Product: Postrelle-2
Active Ingredient: Levonorgestrel 0.75mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Famy Care Limited, Ahmedabad, India
Product: Ramipex
Active Ingredient: Pramipexole hydrochloride monohydrate 0.25mg equivalent to Pramipexole 0.175mg
Dosage Form: Tablet
New Zealand Sponsor: Deva Holdings NZ Limited
Manufacturer: Deva Holding A.S., Tekirdag, Turkey
Product: Ramipex
Active Ingredient: Pramipexole hydrochloride monohydrate 1mg equivalent to Pramipexole 0.7mg
Dosage Form: Tablet
New Zealand Sponsor: Deva Holdings NZ Limited
Manufacturer: Deva Holding A.S., Tekirdag, Turkey
Product: Isentress
Active Ingredient: Raltegravir potassium 434.3mg equivalent to Raltegravir 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Corp, Virginia, United States of America
MSD International GmbH (Singapore Branch), Singapore
Dated this 13th day of February 2014.
SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).