✨ Medicines Consent Notices




NEW ZEALAND GAZETTE, No. 27

6 MARCH 2014

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: DP Fusidic Acid Cream
Active Ingredients: Fusidic acid 20.35mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Basic Pharma Manufacturing BV, Geleen, The Netherlands

Product: First Response 7 Day Pregnancy Planning Kit
Active Ingredients:

  • Antibody to HCG hormone 0.06mcg
  • Goat anti-mouse immunoglobulin G polyclonal antibody 0.4mcg
  • Murine monoclonal antibody to HCG 0.3mcg
    Dosage Form: Pregnancy test kit
    New Zealand Sponsor: Pharmabroker Sales Limited
    Manufacturer: Scantibodies Laboratory Inc., California, United States of America

Product: Hexaxim
Active Ingredients:

  • Diphtheria toxoid, adsorbed 30Lf U equivalent to not less than 20IU
  • Haemophilus influenzae type b polysaccharide 12mcg
  • Hepatitis B virus surface antigen 10mcg
  • Pertussis filamentous haemagglutinin 25mcg
  • Pertussis toxoid, adsorbed 25mcg
  • Polio virus type 1 40DAgU
  • Polio virus type 2 8DAgU
  • Polio virus type 3 32DAgU
  • Tetanus toxoid, adsorbed 10Lf U equivalent to not less than 40IU
    Dosage Form: Suspension for injection
    New Zealand Sponsor: sanofi-aventis new zealand limited
    Manufacturer: Sanofi Pasteur SA, Marcy L’Etoile, France

Product: Riodine Povidone-Iodine Antiseptic Solution
Active Ingredient: Povidone-iodine 100mg/mL equivalent to Iodine 1.0% w/v
Dosage Form: Topical solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Orion Laboratories Pty Limited, Perth, Australia

Product: Stribild
Active Ingredients:

  • Cobicistat 150mg
  • Elvitegravir 150mg
  • Emtricitabine 200mg
  • Tenofovir disoproxil fumarate 300mg
    Dosage Form: Film coated tablet
    New Zealand Sponsor: Gilead Sciences (NZ)
    Manufacturer: Patheon Inc, Ontario, Canada

Dated this 28th day of February 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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Provisional Consent to the Distribution of a New Medicine

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 medicine set out in the Schedule hereto:

Schedule

Product: Panvax vaccine
Active Ingredient: Influenza Virus Type A haemagglutinin 30mcg
Dosage Form: Suspension for injection
New Zealand Sponsor: bioCSL (NZ) Limited
Manufacturer: bioCSL Pty Limited, Melbourne, Australia



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2014, No 27





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
28 February 2014
Medicines, Consent, Distribution, New Zealand
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health

πŸ₯ Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
28 February 2014
Medicines, Provisional Consent, Distribution, New Zealand
  • STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health