✨ Medicines Act Notices




Health

Medicines Act 1981

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: Cytraccord
Active Ingredient: Cytarabine 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India

Product: Momiston
Active Ingredient: Mometasone furoate 0.1%w/w
Dosage Form: Topical ointment
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Glenmark Pharmaceuticals Limited, Himachal Pradesh, India

Product: Paracode Plus
Active Ingredients: Codeine phosphate hemihydrate 15mg
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Adcock Ingram Limited – A Medreich Group Company, Bangalore, India

Product: Parafast
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Marksans Pharma Limited, Goa, India

Dated this 28th day of April 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).

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: Ketamine
Active Ingredient: Ketamine hydrochloride 1mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This consent is valid for two years from the date of publication of this notice.

Product: Ketamine
Active Ingredient: Ketamine hydrochloride 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This consent is valid for two years from the date of publication of this notice.

Product: Ketamine
Active Ingredient: Ketamine hydrochloride 4mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Note: This consent is valid for two years from the date of publication of this notice.



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 59





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
28 April 2011
Medicines Act 1981, New medicines, Distribution consent, Pharmaceuticals
  • PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Provisional Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
28 April 2011
Medicines Act 1981, Provisional consent, New medicines, Pharmaceuticals
  • PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health