β¨ 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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β¨ LLM interpretation of page content
π₯
Consent to Distribution of New Medicine
(continued from previous page)
π₯ Health & Social Welfare12 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
π₯ Renewal of Provisional Consent to the Distribution of a Medicine
π₯ Health & Social Welfare12 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
π₯ Temporary Class Drug Notice
π₯ Health & Social Welfare17 December 2012
Misuse of Drugs Act 1975, AM-2233, Temporary Class Drug
- HON PETER DUNNE, Associate Minister of Health
NZ Gazette 2012, No 151