✨ 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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✨ LLM interpretation of page content
🏥 Consent to Distribution of New Medicines
🏥 Health & Social Welfare3 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 Welfare3 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 Welfare3 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
NZ Gazette 2008, No 156