Medicines Approval Notices




29 OCTOBER 2009 NEW ZEALAND GAZETTE, No. 157 3815

Product: Flamazine (Prescription)
Active Ingredient: Sulfadiazine silver 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Smith & Nephew Limited (NZ)
Manufacturer: Solvay Pharma SA, Santiago Ramon y Cajal, Parets Del Valles, Barcelona, Spain

Product: Flamazine (Pharmacy Only)
Active Ingredient: Sulfadiazine silver 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Smith & Nephew Limited (NZ)
Manufacturer: Solvay Pharma SA, Santiago Ramon y Cajal, Parets Del Valles, Barcelona, Spain

Product: Oxaliplatin
Active Ingredient: Oxaliplatin 100mg
Dosage Form: Powder for infusion
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Manufacturing Division, Verna, Salcette, Goa, India

Dated this 22nd day of October 2009.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, 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 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: Tisseel Fibrin Sealant VH S/D
Active Ingredients:
Aprotinin 2250kIU – 3750kIU
Factor XIII 1.2IU/mL – 10IU/mL
Fibrinogen 72mg/mL – 110mg/mL
Dosage Form: Syringe 1 Topical solution
Active Ingredients:
Calcium chloride dihydrate 0.4mmol/L
Thrombin 500IU/mL
Dosage Form: Syringe 2 Topical solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter AG, Vienna, Austria

Dated this 22nd day of October 2009.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding 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 a New Medicine

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 medicine set out in the Schedule hereto:

Schedule

Product: Actigall
Active Ingredient: Ursodeoxycholic acid 300mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Watson Laboratories Inc, Carmel, New York, United States of America

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 22nd day of October 2009.

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

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Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2009, No 157





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
22 October 2009
Medicines Act 1981, New Medicines, Flamazine, Oxaliplatin
  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health

🏥 Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
22 October 2009
Medicines Act 1981, New Medicine, Tisseel Fibrin Sealant VH S/D
  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health

🏥 Provisional Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
22 October 2009
Medicines Act 1981, Provisional Consent, Actigall
  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health

🏥 Renewal of Provisional Consent to the Distribution of a Medicine

🏥 Health & Social Welfare
22 October 2009
Medicines Act 1981, Provisional Consent Renewal
  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health