✨ Medicine Distribution Consents




1966 NEW ZEALAND GAZETTE, No. 66 17 JUNE 2010

Product: Lanzol Relief
Active Ingredient: Lansoprazole 30mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India

Product: Lanzol Relief
Active Ingredient: Lansoprazole 15mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India

Product: Pantoprazole Sandoz
Active Ingredient: Pantoprazole sodium sesquihydrate 22.55mg equivalent to 20mg pantoprazole
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Ilac Sanayi ve Ticaret Anonim Sirketi, Gebze, Turkey

Product: Pantoprazole Sandoz
Active Ingredient: Pantoprazole sodium sesquihydrate 45.1mg equivalent to 40mg pantoprazole
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz Ilac Sanayi ve Ticaret Anonim Sirketi, Gebze, Turkey

Product: Tasigna
Active Ingredient: Nilotinib hydrochloride monohydrate 220.6mg equivalent to 200mg nilotinib
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: UREX FORTE
Active Ingredient: Furosemide 500mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Sigma Pharmaceuticals Australia Pty Limited, Baulkham Hills, Australia

Dated this 10th day of June 2010.

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, 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 New Medicines

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 medicines set out in the Schedule hereto:

Schedule

Product: Viramune
Active Ingredient: Nevirapine 200mg
Dosage Form: Tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Roxane Inc, Columbus, United States of America
Note: This consent is valid for two years from the date of publication of this notice.

Product: Viramune
Active Ingredient: Nevirapine hemihydrate 10.35mg/mL equivalent 10mg/mL nevirapine
Dosage Form: Oral suspension
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Roxane Inc, Columbus, United States of America
Note: This consent is valid for two years from the date of publication of this notice.

Dated this 10th day of June 2010.

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 66





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
10 June 2010
Medicines, Distribution Consent, Lanzol Relief, Pantoprazole Sandoz, Tasigna, UREX FORTE
  • STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

πŸ₯ Provisional Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
10 June 2010
Medicines, Provisional Consent, Viramune
  • STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health