✨ Medicines Consent Notices




3478 NEW ZEALAND GAZETTE, No. 122 4 OCTOBER 2012

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 medicine set out in the Schedule hereto:

Schedule

Product: Aclovax (General sale)
Active Ingredient: Aciclovir 5%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Oman Pharmaceutical Products Company LLC, Salalah, Oman

Product: Aclovax (Pharmacy only)
Active Ingredient: Aciclovir 5%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Oman Pharmaceutical Products Company LLC, Salalah, Oman

Product: Arrow - Pantop
Active Ingredient: Pantoprazole sodium sesquihydrate 45.112mg equivalent to Pantoprazole 40mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Goa, India

Product: AS-Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 11.4mg/mL equivalent to Gemcitabine 10mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India

Product: Colgate NeutraFluor 5000 Gel
Active Ingredient: Sodium fluoride 1.105%w/w equivalent to Fluoride 5000ppm
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited (NZ)
Manufacturer: Colgate Oral Pharmaceuticals, Texas, United States of America

Product: Exforge HCT
Active Ingredients:

  • Amlodipine besilate 6.94mg equivalent to Amlodipine 5mg
  • Hydrochlorothiazide 12.5mg
  • Valsartan 160mg
    Dosage Form: Film coated tablet
    New Zealand Sponsor: Novartis New Zealand Limited
    Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: Exforge HCT
Active Ingredients:

  • Amlodipine besilate 6.94mg equivalent to Amlodipine 5mg
  • Hydrochlorothiazide 25mg
  • Valsartan 160mg
    Dosage Form: Film coated tablet
    New Zealand Sponsor: Novartis New Zealand Limited
    Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: Exforge HCT
Active Ingredients:

  • Amlodipine besilate 13.87mg equivalent to Amlodipine 10mg
  • Hydrochlorothiazide 12.5mg
  • Valsartan 160mg
    Dosage Form: Film coated tablet
    New Zealand Sponsor: Novartis New Zealand Limited
    Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: Exforge HCT
Active Ingredients:

  • Amlodipine besilate 13.87mg equivalent to Amlodipine 10mg
  • Hydrochlorothiazide 25mg
  • Valsartan 160mg
    Dosage Form: Film coated tablet
    New Zealand Sponsor: Novartis New Zealand Limited
    Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland


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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2012, No 122





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, New medicines, Distribution consent