New Zealand Gazette – 2012 – No. 37

Page 1103

✨ Medicines Consent Notices

29 MARCH 2012 NEW ZEALAND GAZETTE, No. 37 1103

Product: Oxycodone Orion
Active Ingredient: Oxycodone hydrochloride 10mg
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Orion Corporation, Espoo, Finland

Product: Saphris
Active Ingredient: Asenapine maleate 7.03mg equivalent to asenapine 5mg
Dosage Form: Wafer
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Catalent UK Swindon Zydis Limited, Wiltshire, United Kingdom

Product: Saphris
Active Ingredient: Asenapine maleate 14.06mg equivalent asenapine 10mg
Dosage Form: Wafer
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Catalent UK Swindon Zydis Limited, Wiltshire, United Kingdom

Dated this 22nd day of March 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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Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product: Gardasil
Active Ingredients:

Human Papillomavirus (HPV) 11 L1 Protein 80μg/mL
Human Papillomavirus (HPV) 16 L1 Protein 80μg/mL
Human Papillomavirus (HPV) 18 L1 Protein 40μg/mL
Human Papillomavirus (HPV) 6 L1 Protein 40μg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers:
Merck Sharp & Dohme Corp, Pennsylvania, United States of America
Merck Sharp & Dohme BV, Haarlem, The Netherlands

Dated this 22nd day of March 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 Medicines

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 medicines set out in the Schedule hereto:

Schedule

Product: Benztrop
Active Ingredient: Benzatropine mesilate 2mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, Quebec, Canada
Note: This renewed consent is valid for two years from 13 May 2012.

Product: Clozaril
Active Ingredient: Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharmaceuticals UK Limited, West Sussex, United Kingdom
Note: This consent is given subject to the following conditions:

The medicine may only be prescribed by:
- Registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry; and
- Medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of persons of the kind referred to above.

Gazette.govt.nz — NZ Gazette 2012, No 37

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
Dated22 March 2012
KeywordsMedicines Act 1981, Oxycodone, Saphris, New Zealand Sponsor, Manufacturer
👩‍💼 Officials

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

🏥 Consent to the Distribution of Gardasil

Domain🏥 Health & Social Welfare
Dated22 March 2012
KeywordsMedicines Act 1981, Gardasil, Human Papillomavirus, New Zealand Sponsor, Manufacturer
👩‍💼 Officials

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

🏥 Renewal of Provisional Consent to the Distribution of Medicines

Domain🏥 Health & Social Welfare
Dated22 March 2012
KeywordsMedicines Act 1981, Benztrop, Clozaril, Renewal, Provisional Consent
👩‍💼 Officials

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

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