Medicines Act Notices




NEW ZEALAND GAZETTE, No. 39

4 APRIL 2013


Health


Medicines Act 1981

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 set out in the Schedule hereto:

Schedule

Product: Hospira™ Cefazolin Sodium Powder for Injection
Active Ingredient: Cefazolin sodium 1.048g equivalent to Cefazolin 1g
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Healthcare India Pvt. Limited, Tamil Nadu, India

Dated this 28th day of March 2013.

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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Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) 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: Rilutek
Active Ingredient: Riluzole 50mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Winthrop Industrie, Compiegne, France

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

Rilutek can only be prescribed by specialist physicians who care for patients with Motor Neurone Disease, neurologists and palliative care physicians.

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 28th day of March 2013.

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 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 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: Avastin
Active Ingredient: Bevacizumab 25mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers:
Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Genentech Inc, California, United States of America

Product: Nupentin
Active Ingredient: Gabapentin 100mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Australia



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 39





✨ LLM interpretation of page content

🏥 Consent to the Distribution of a New Medicine - Hospira™ Cefazolin Sodium Powder for Injection

🏥 Health & Social Welfare
28 March 2013
Medicines Act, New Medicine, Distribution Consent, Hospira, Cefazolin Sodium
  • Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Provisional Consent to the Distribution of a New Medicine - Rilutek

🏥 Health & Social Welfare
28 March 2013
Medicines Act, Provisional Consent, New Medicine, Rilutek, Riluzole
  • Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Consent to the Distribution of New Medicines - Avastin and Nupentin

🏥 Health & Social Welfare
28 March 2013
Medicines Act, New Medicines, Distribution Consent, Avastin, Nupentin
  • Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health