✨ 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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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 67





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of a New Medicine - Voltaren Emulgel

πŸ₯ Health & Social Welfare
12 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

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines Act, New Medicines, Dialysis solution, Fluconazole, Lamivudine, Fresenius, Ipca, Mylan