Medicines Approval Notices




9 OCTOBER 2008

NEW ZEALAND GAZETTE, No. 156

4089

Product:
Exforge

Active Ingredients:
Amlodipine besilate 6.94mg equivalent to 5mg amlodipine
Valsartan 160mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturers:
Novartis Pharma Stein AG, Stein, Switzerland

Product:
Exforge

Active Ingredients:
Amlodipine besilate 6.94mg equivalent to 5mg amlodipine
Valsartan 80mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturers:
Novartis Pharma Stein AG, Stein, Switzerland

Product:
Terbinafine

Active Ingredient:
Terbinafine hydrochloride 281.25mg equivalent to 250mg terbinafine

Dosage Form:
Tablet

New Zealand Sponsor:
Affordable Healthcare Limited

Manufacturer:
Dr Reddy’s Laboratories Limited, Generics, Bachepalli, Andhra Pradesh, India

Dated this 3rd day of October 2008.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

go7520

Consent to the Distribution of a Changed 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 medicines set out in the Schedule hereto:

Schedule

Product:
Betaloc CR

Active Ingredient:
Metoprolol succinate 23.75mg

Dosage Form:
Modified release tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturers:
AstraZeneca AB, Gartunavagen, Södertälje, Sweden

Product:
Betaloc CR

Active Ingredient:
Metoprolol succinate 190mg

Dosage Form:
Modified release tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer:
AstraZeneca AB, Gartunavagen, Södertälje, Sweden

Product:
Betaloc CR

Active Ingredient:
Metoprolol succinate 47.5mg

Dosage Form:
Modified release tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer:
AstraZeneca AB, Gartunavagen, Södertälje, Sweden

Product:
Betaloc CR

Active Ingredient:
Metoprolol succinate 95mg

Dosage Form:
Modified release tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer:
AstraZeneca AB, Gartunavagen, Södertälje, Sweden

Dated this 3rd day of October 2008.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

go7521

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:
Orencia

Active Ingredient:
Abatacept 250mg

Dosage Form:
Powder for injection

New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited

Manufacturer:
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2008, No 156





✨ LLM interpretation of page content

🏥 Consent to Distribution of New Medicines

🏥 Health & Social Welfare
3 October 2008
Medicines, Distribution, Medicines Act 1981, New Medicines
  • Mark Richards, Acting Deputy Director-General signing consent

  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Consent to Distribution of Changed Medicine

🏥 Health & Social Welfare
3 October 2008
Medicines, Distribution, Medicines Act 1981, Changed Medicines
  • Mark Richards, Acting Deputy Director-General signing consent

  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Provisional Consent to Distribution of New Medicine

🏥 Health & Social Welfare
3 October 2008
Medicines, Provisional Consent, Medicines Act 1981, New Medicines
  • Mark Richards, Acting Deputy Director-General signing consent

  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate