New Zealand Gazette – 2006 – No. 114

Page 3374

✨ Medicines Distribution Consents

3374 NEW ZEALAND GAZETTE, No. 114 5 OCTOBER 2006

Product:
Periset
Active Ingredient:
Ondansetron hydrochloride dihydrate 5mg equivalent to ondansetron 4mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Bristol Pharma (New Zealand) Pty Limited
Manufacturer:
IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India

Product:
Periset
Active Ingredient:
Ondansetron hydrochloride dihydrate 10mg equivalent to ondansetron 8mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Bristol Pharma (New Zealand) Pty Limited
Manufacturer:
IPCA Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India

Product:
Stocrin
Active Ingredient:
Efavirenz 200mg
Dosage Form:
Tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturer:
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia

Product:
Stocrin
Active Ingredient:
Efavirenz 50mg
Dosage Form:
Tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturer:
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia

Dated this 28th day of September 2006.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

go6848

Consent to the Distribution of Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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:
Botox
Active Ingredient:
Botulinum A toxin 100U
Dosage Form:
Powder for injection
New Zealand Sponsor:
Allergan New Zealand Limited
Manufacturer:
Allergan Pharmaceuticals Ireland, Westport, County Mayo, Ireland

Product:
Mabthera
Active Ingredient:
Rituximab 10mg/mL
Dosage Form:
Concentrate for infusion
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturers:
F Hoffmann-La Roche AG, Basel, Switzerland
Genentech Inc, South San Francisco, California, United States of America

Dated this 28th day of September 2006.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

go6847

Renewal of Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 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:

Schedule

Product:
Zopine
Active Ingredient:
Clozapine 100mg
Dosage Form:
Tablet
New Zealand Sponsor:
Pacific Pharmaceuticals Limited
Manufacturer:
Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia

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

The medicine may only be prescribed by medical practitioners who are vocationally registered under the Health Practitioners Competence Act 2003 in the branches of psychological medicine or psychiatry employed as registrars in psychological medicine or psychiatry who are under the supervision of persons of the kind referred to above.
Persons prescribing the medicine must comply with the requirements of the New Zealand Guidelines for the Use of Atypical Anti-Psychotic Drugs (Third Edition January 2002), and the requirements of local hospital and health service protocols for the use of clozapine.

VUW Te Waharoa — NZ Gazette 2006, No 114

Gazette.govt.nz — NZ Gazette 2006, No 114

Parliament House (depicted) was completed in 1918 and remains the primary seat of Parliament.

✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

Domain🏥 Health & Social Welfare
Dated28 September 2006
KeywordsMedicines Act, New Medicines, Distribution Consent, Periset, Stocrin
👩‍💼 Officials

DON MATHESON, Deputy Director-General, Public Health

🏥 Consent to the Distribution of Changed Medicines

Domain🏥 Health & Social Welfare
Dated28 September 2006
KeywordsMedicines Act, Changed Medicines, Distribution Consent, Botox, Mabthera
👩‍💼 Officials

DON MATHESON, Deputy Director-General, Public Health

🏥 Renewal of Provisional Consent to the Distribution of a New Medicine

Domain🏥 Health & Social Welfare
Dated28 September 2006
KeywordsMedicines Act, Provisional Consent, New Medicine, Zopine, Clozapine
👩‍💼 Officials

DON MATHESON, Deputy Director-General, Public Health

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