✨ Medicines Consent Notices




20 DECEMBER 2012

NEW ZEALAND GAZETTE, No. 151

4469

Product:
CA - Hydroxychloroquine

Active Ingredient:
Hydroxychloroquine sulfate 200mg

Dosage Form:
Coated tablet

New Zealand Sponsor:
Arrow Pharmaceuticals (NZ) Limited

Manufacturer:
Ipca Laboratories Limited, Silvassa, India

Product:
Clonidine BNM

Active Ingredient:
Clonidine hydrochloride 25mcg

Dosage Form:
Tablet

New Zealand Sponsor:
Boucher & Muir (New Zealand) Limited t/a BNM Group

Manufacturers:
Bafna Pharmaceuticals Limited, Chennai, India
Tiofarma B.V, Oud-Beijerland, The Netherlands

Product:
Evogam

Active Ingredient:
Normal immunoglobulin 16%w/v

Dosage Form:
Solution for injection

New Zealand Sponsor:
CSL Biotherapies (NZ) Limited

Manufacturer:
CSL Limited, Melbourne, Australia

Product:
IPCA - Hydroxychloroquine

Active Ingredient:
Hydroxychloroquine sulfate 200mg

Dosage Form:
Coated tablet

New Zealand Sponsor:
Arrow Pharmaceuticals (NZ) Limited

Manufacturer:
Ipca Laboratories Limited, Silvassa, India

Product:
Lacdol

Active Ingredient:
Lactulose 0.67g/mL

Dosage Form:
Oral solution

New Zealand Sponsor:
Arrow Pharmaceuticals (NZ) Limited

Manufacturer:
Drug Houses of Australia Private Limited, Singapore

Dated this 12th day of December 2012.

DR STEWART JESSAMINE, 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).

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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:
Proleukin

Active Ingredient:
Aldesleukin 18MIU

Dosage Form:
Powder for injection

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturers:
Novartis Pharmaceuticals UK Limited, West Sussex, United Kingdom
Bayer HealthCare Pharmaceuticals Inc, Emeryville, United States of America

Note: This renewed consent is valid for two years from 27 January 2013.

Dated this 12th day of December 2012.

DR STEWART JESSAMINE, 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).

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Misuse of Drugs Act 1975

Temporary Class Drug Notice

Pursuant to section 4E of the Misuse of Drugs Act 1975, I give notice that the following substance is renewed as a temporary class drug:

AM-2233
1-[(N-methylpiperidin-2-yl)methyl]-3-(2-iodobenzoyl)indole

This notice will take effect on 30 December 2012 and will expire on 29 December 2013, unless otherwise revoked as specified in section 4E of the Misuse of Drugs Act 1975.

Dated at Wellington this 17th day of December 2012.

HON PETER DUNNE, Associate Minister of Health.

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2012, No 151





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicine (continued from previous page)

πŸ₯ Health & Social Welfare
12 December 2012
Medicines Act 1981, Hydroxychloroquine sulfate, Clonidine hydrochloride, Normal immunoglobulin, Lactulose, Arrow Pharmaceuticals (NZ) Limited, Boucher & Muir (New Zealand) Limited, CSL Biotherapies (NZ) Limited
  • DR STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of a Medicine

πŸ₯ Health & Social Welfare
12 December 2012
Medicines Act 1981, Aldesleukin, Proleukin, Novartis New Zealand Limited
  • DR STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Temporary Class Drug Notice

πŸ₯ Health & Social Welfare
17 December 2012
Misuse of Drugs Act 1975, AM-2233, Temporary Class Drug
  • HON PETER DUNNE, Associate Minister of Health