โœจ Medicines Act Notices




448 NEW ZEALAND GAZETTE, No. 13 7 FEBRUARY 2013

Health

Medicines Act 1981

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:

Schedule

Product: Cal.D.Forte

Active Ingredient: Colecalciferol 1.25mg equivalent to 50,000IU

Dosage Form: Coated tablet

New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands

Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

Note: This renewed consent is valid for one year from 12 February 2013.

Dated this 31st day of January 2013.

DR DON MACKIE, 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: Arrow โ€“ Clopid

Active Ingredient: Clopidogrel bisulfate 97.875mg equivalent to Clopidogrel 75mg

Dosage Form: Film coated tablet

New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited

Manufacturer: Macleods Pharmaceuticals Limited, Himachal Pradesh, India

Product: Refresh Night Timeยฎ

Active Ingredients:

  • Liquid paraffin 42.5%w/w
  • White soft paraffin 57.3%w/w

Dosage Form: Eye ointment

New Zealand Sponsor: Allergan New Zealand Limited

Manufacturer: Allergan Sales LLC, Texas, United States of America

Dated this 31st day of January 2013.

DR DON MACKIE, 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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Adacel

Active Ingredients:

  • Diphtheria toxoid, adsorbed 2IU
  • Pertactin 3mcg
  • Pertussis filamentous haemagglutinin 5mcg
  • Pertussis fimbriae 2+3 5mcg
  • Pertussis toxoid, adsorbed 2.5mcg
  • Tetanus toxoid 20IU

Dosage Form: Suspension for injection

New Zealand Sponsor: sanofi-aventis new zealand limited

Manufacturer: Sanofi Pasteur Limited, Ontario, Canada



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 13





โœจ LLM interpretation of page content

๐Ÿฅ Renewal of Provisional Consent to the Distribution of a Medicine

๐Ÿฅ Health & Social Welfare
31 January 2013
Medicines Act 1981, Provisional Consent Renewal, Cal.D.Forte, Colecalciferol
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

๐Ÿฅ Consent to the Distribution of New Medicines

๐Ÿฅ Health & Social Welfare
31 January 2013
Medicines Act 1981, New Medicine Consent, Arrow โ€“ Clopid, Refresh Night Timeยฎ
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

๐Ÿฅ Consent to the Distribution of New Medicines

๐Ÿฅ Health & Social Welfare
31 January 2013
Medicines Act 1981, New Medicine Consent, Adacel, Vaccine
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health