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: Binocrit
Active Ingredient: Epoetin alfa 16.8µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: IDT Biologika GmbH, Dessau Rosslau, Germany
Product: Binocrit
Active Ingredient: Epoetin alfa 84µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: IDT Biologika GmbH, Dessau Rosslau, Germany
Product: Binocrit
Active Ingredient: Epoetin alfa 336µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: IDT Biologika GmbH, Dessau Rosslau, Germany
Product: Ferinject
Active Ingredient: Ferric carboxymaltose 180mg equivalent to Iron 50mg
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Nycomed GmbH, Singen, Germany
Product: Hospira™ Ceftriaxone Sodium Powder for Injection
Active Ingredient: Ceftriaxone sodium 1.19g equivalent to Ceftriaxone 1g
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Healthcare India Pvt. Limited, Tamil Nadu, India
Product: Hospira™ Ceftriaxone Sodium Powder for Injection
Active Ingredient: Ceftriaxone sodium 2.39g equivalent to Ceftriaxone 2g
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Healthcare India Pvt. Limited, Tamil Nadu, India
Dated this 29th day of March 2012.
DR PAT TUOHY, Acting 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).