New Zealand Gazette – 2010 – No. 58

Page 1653

✨ Medicines Notices

20 MAY 2010 NEW ZEALAND GAZETTE, No. 58 1653

Health

Medicines Act 1981

Corrigendum—Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health renewed the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule to a notice published in the New Zealand Gazette, 8 April 2010, No. 40, page 1159.

This corrigendum amends the notice by replacing the entry with the following renewal of provisional consent to the distribution of a medicine.

Schedule

Product: HyperHep B
Active Ingredient: Hepatitis B immunoglobulin, human 220IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: EastMed Pharmacy Limited t/a EastMed Logistics
Manufacturer: Talecris Biotherapeutics Inc, Clayton, United States of America

Note: This renewed consent is valid for two years from 8 May 2010.

Dated this 13th day of May 2010.

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, 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 set out in the Schedule hereto:

Schedule

Product: Arrow - Ranitidine
Active Ingredient: Ranitidine hydrochloride 16.75mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Rosemont Pharmaceuticals Limited, Leeds, United Kingdom

Product: Benadryl Mucus Relief & Decongestant
Active Ingredients: Guaifenesin 20mg/mL
Phenylephrine hydrochloride 1mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Laverton North, Australia

Product: Dr Reddy’s Omeprazole
Active Ingredient: Omeprazole 20mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India

Product: Locacorten-Viaform
Active Ingredients: Clioquinol 1%w/v
Flumetasone pivalate 0.02%w/v
Dosage Form: Ear drops
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Famar SA, Athens, Greece

Product: Vidaza
Active Ingredient: Azacitidine 100mg
Dosage Form: Suspension for injection
New Zealand Sponsor: Celgene Pty Limited Quigg Partners
Manufacturers: Ben Venue Laboratories Inc, Bedford, United States of America
Baxter Oncology GmbH, Halle-Kunsebeck, Germany

Dated this 13th day of May 2010.

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, 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 2010, No 58

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

🏥 Corrigendum—Renewal of Provisional Consent to the Distribution of a Medicine

Domain🏥 Health & Social Welfare
Dated13 May 2010
KeywordsMedicines, Provisional Consent, Renewal, Corrigendum, HyperHep B
👩‍💼 Officials

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

🏥 Consent to the Distribution of New Medicines

Domain🏥 Health & Social Welfare
Dated13 May 2010
KeywordsMedicines, Consent, Distribution, Arrow - Ranitidine, Benadryl Mucus Relief & Decongestant, Dr Reddy’s Omeprazole, Locacorten-Viaform, Vidaza
👩‍💼 Officials

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

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