New Zealand Gazette – 2012 – No. 88

Page 2432

✨ Medicine Distribution Consents

2432 NEW ZEALAND GAZETTE, No. 88 26 JULY 2012

Product: Dr Reddy’s Sertraline
Active Ingredient: Sertraline hydrochloride 111.92mg equivalent to Sertraline 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: Oratane
Active Ingredient: Isotretinoin 30mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Swiss Caps AG, Kirchberg, Switzerland

Product: Prokinex
Active Ingredient: Domperidone maleate 12.72mg equivalent to Domperidone 10mg
Dosage Form: Tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India

Product: Sertraline-DRLA
Active Ingredient: Sertraline hydrochloride 55.96mg equivalent to Sertraline 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: Sertraline-DRLA
Active Ingredient: Sertraline hydrochloride 111.92mg equivalent to Sertraline 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: Victrelis
Active Ingredient: Boceprevir 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Schering-Plough Limited, Singapore City, Singapore

Dated this 19th day of July 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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Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Product: Pandemic Influenza Vaccine H5N1 Baxter
Active Ingredient: Influenza vaccine whole virion, vero cell derived, inactivated, H5N1 7.5µg
Dosage Form: Suspension for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter AG, Vienna, Austria

Note: This consent is given subject to the following condition:

The vaccine may only be marketed or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.

Note: This renewed consent is valid for two years from 5 August 2012.

Dated this 19th day of July 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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Gazette.govt.nz — NZ Gazette 2012, No 88

The General Assembly Library (on the right) was completed in 1899 and survived the 1907 fire. Now the oldest remaining original Parliament building, still used as the Parliamentary Library.

✨ LLM interpretation of page content

🏥 Consent to Distribution of New Medicines

Domain🏥 Health & Social Welfare
Dated19 July 2012
KeywordsMedicines, Distribution, Consent, New Medicines, Health
👩‍💼 Officials

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

🏥 Renewal of Provisional Consent to Distribution of Medicine

Domain🏥 Health & Social Welfare
Dated19 July 2012
KeywordsMedicines, Provisional Consent, Renewal, Vaccine, Influenza
👩‍💼 Officials

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

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