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: Intanza
Active Ingredients: Influenza virus A/California/7/2009 (H1N1) - like strain 9µg
Influenza virus A/Perth/16/2009 (H3N2) - like strain 9µg
Influenza virus B/Brisbane/60/2008 - like strain 9µg
Dosage Form: Suspension for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Pasteur SA, Val-De-Reuil Cedex, France
Product: Intanza
Active Ingredients: Influenza virus haemagglutinin 15µg
Influenza virus type A haemagglutinin 15µg
Influenza virus type B haemagglutinin 15µg
Dosage Form: Suspension for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Pasteur SA, Val-De-Reuil Cedex, France
Product: Losartan Potassium 100 mg Tablets
Active Ingredient: Losartan potassium 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Losartan Potassium 25 mg Tablets
Active Ingredient: Losartan potassium 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Losartan Potassium 50 mg Tablets
Active Ingredient: Losartan potassium 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Olanzapine
Active Ingredient: Olanzapine 5mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Olanzapine
Active Ingredient: Olanzapine 10mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Qlaira (Calendar combination pack with four compositions of film-coated tablets)
Active Ingredient: Oestradiol valerate 3mg
Active Ingredients: Dienogest 2mg
Oestradiol valerate 2mg
Active Ingredients: Dienogest 3mg
Oestradiol valerate 2mg
Active Ingredient: Oestradiol valerate 1mg
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Schering GmbH und Co Produktions KG, Weimar, Germany
Product: Ranitidine Relief
Active Ingredient: Ranitidine hydrochloride 167.5mg equivalent to Ranitidine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bangalore, India
Product: Ranitidine Relief
Active Ingredient: Ranitidine hydrochloride 335 equivalent to Ranitidine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bangalore, India
Dated this 15th day of February 2010.
ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).