Medicines Consent Notices




NEW ZEALAND GAZETTE, No. 138

7 OCTOBER 2010

Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Ermington, Australia
Product: Pharmacist’s Own Pain Relief
Active Ingredients:

  • Codeine phosphate hemihydrate 10mg
  • Paracetamol 500mg

Dosage Form: Tablet
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Product: SOMAC Heartburn Relief
Active Ingredient: Pantoprazole sodium sesquihydrate 22.57mg equivalent to pantoprazole 20mg

Dosage Form: Enteric coated tablet
New Zealand Sponsor: Research Associates Limited
Manufacturers:

  • Nycomed GmbH, Oranienburg, Germany
  • Advance Pharma GmbH, Berlin, Germany
    Product: Sulphacetamide Sodium Eye Drops
    Active Ingredient: Sulfacetamide sodium monohydrate 100mg/mL

Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: Alcon Manufacturing Limited, Forth Worth, United States of America

Product: Taxotere
Active Ingredient: Docetaxel, anhydrous 20mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Pharma, Essex, United Kingdom

Product: Taxotere
Active Ingredient: Docetaxel, anhydrous 40mg/mL
Dosage Form: Solution for Concentrate for infusion
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers:

  • Sanofi Chimie, Vitry-Sur-Seine, France
  • Aventis Pharma, Essex, United Kingdom
  • Pierre Fabre Medicament Production, Idron, France

Product: Telfast
Active Ingredient: Fexofenadine hydrochloride 60mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: sanofi-aventis us llc, Kansas City, United States of America

Product: Telfast
Active Ingredient: Fexofenadine hydrochloride 120mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: sanofi-aventis us llc, Kansas City, United States of America

Dated this 30th day of September 2010.

JANICE WILSON, Deputy Director-General, Population Health 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: Cerumol Ear Drops
Active Ingredients:

  • Arachis oil 57%v/v
  • Chlorobutanol, anhydrous 5%w/v
  • Orthodichlorobenzene 14.5%w/v
  • Paradichlorobenzene 2%v/v
    Dosage Form: Ear drops


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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 138





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
30 September 2010
Medicines, Consent, Distribution, New Zealand, Pharmaceuticals
  • JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health

🏥 Consent to the Distribution of a New Medicine

🏥 Health & Social Welfare
Medicine, Consent, Distribution, Cerumol Ear Drops