โจ 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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โจ LLM interpretation of page content
๐ฅ Renewal of Provisional Consent to the Distribution of a Medicine
๐ฅ Health & Social Welfare31 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
๐ฅ Consent to the Distribution of New Medicines
๐ฅ Health & Social Welfare31 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
๐ฅ Consent to the Distribution of New Medicines
๐ฅ Health & Social Welfare31 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
NZ Gazette 2013, No 13