New Zealand Gazette – 2012 – No. 29

Page 832

✨ Medicines Distribution Consents

832 NEW ZEALAND GAZETTE, No. 29 8 MARCH 2012

Product: Bicalutamide
Active Ingredient: Bicalutamide 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: Elonva
Active Ingredient: Corifollitropin alfa 0.2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Product: Elonva
Active Ingredient: Corifollitropin alfa 0.3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Product: Menactra
Active Ingredient: Meningococcal polysaccharide 4μg of each of Groups A, C, Y & W-135, each separately conjugated to diphtheria toxoid, 48μg total
Dosage Form: Solution for injection
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturer: Sanofi Pasteur Inc, Pennsylvania, United States of America

Product: Viramune
Active Ingredient: Nevirapine 200mg
Dosage Form: Tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Roxane Inc, Ohio, United States of America

Product: Viramune
Active Ingredient: Nevirapine hemihydrate 10.35mg/mL equivalent to Nevirapine 10mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Roxane Inc, Ohio, United States of America

Dated this 1st day of March 2012.

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).

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Consent to the Distribution of New Medicines

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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Micardis
Active Ingredient: Telmisartan 40mg
Dosage Form: Tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product: Micardis
Active Ingredient: Telmisartan 80mg
Dosage Form: Tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Dated this 1st day of March 2012.

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).

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Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Gazette.govt.nz — NZ Gazette 2012, No 29

The Executive Wing of Parliament (depicted) is universally known as The Beehive. It was completed in 1977 and remains the primary office for the elected Government of the day.

✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

Domain🏥 Health & Social Welfare
Dated1 March 2012
KeywordsMedicines Act, New Medicines, Distribution, Bicalutamide, Elonva, Menactra, Viramune
👩‍💼 Officials

Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Consent to the Distribution of New Medicines

Domain🏥 Health & Social Welfare
Dated1 March 2012
KeywordsMedicines Act, New Medicines, Distribution, Micardis, Telmisartan
👩‍💼 Officials

Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Provisional Consent to the Distribution of a New Medicine

Domain🏥 Health & Social Welfare
KeywordsMedicines Act, Provisional Consent, New Medicine

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