β¨ Medicines Act Notices
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 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: Voltaren Emulgel
Active Ingredient: Diclofenac diethylamine 1.16% equivalent to 1% diclofenac
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturers: Novartis Consumer Health SA, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany
Dated this 12th day of May 2011.
PAT TUOHY, Acting 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 set out in the Schedule hereto:
Schedule
Product: Concentrated Haemodialysis Solution - AC-F 2155G Part A
Active Ingredients: Acetic acid 8.4g/L
Calcium chloride dihydrate 7.7g/L
Glucose 34.7g/L
Magnesium chloride 3.6g/L
Potassium chloride 5.2g/L
Sodium chloride 214.8g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Fresenius Medical Care Australia Pty Limited (NZ)
Manufacturer: Fresenius Medical Care Australia Pty Limited, Smithfield, Australia
Product: Flucasten 150mg capsule
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Fluconazole 150mg capsule
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: I-Fluconazole 150mg capsule
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Lamivudine Alphapharm
Active Ingredient: Lamivudine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Maharashtra State, India
Product: Lamivudine Alphapharm
Active Ingredient: Lamivudine 300mg
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β¨ LLM interpretation of page content
π₯ Consent to the Distribution of a New Medicine - Voltaren Emulgel
π₯ Health & Social Welfare12 May 2011
Medicines Act, New Medicine, Voltaren Emulgel, Diclofenac, Topical gel, Novartis
- PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social WelfareMedicines Act, New Medicines, Dialysis solution, Fluconazole, Lamivudine, Fresenius, Ipca, Mylan
NZ Gazette 2011, No 67