Medicines Act Notices




6 OCTOBER 2011 NEW ZEALAND GAZETTE, No. 150 4291


Health


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 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: Menevit
Active Ingredients:

  • Calcium ascorbate dihydrate 121mg
  • D-alpha Tocoferol 400IU
  • Folic acid 500µg
  • Garlic oil 333µg
  • Lycopene 6mg
  • Selenomethionine 4.975mg equivalent to 26µg selenium added as Selenomethionine DCP
  • Zinc sulfate monohydrate 69.2mg equivalent to 25mg zinc
    Dosage Form: Capsule
    New Zealand Sponsor: Bayer New Zealand Limited
    Manufacturer: Catalent Australia Pty Limited, Braeside, Australia

Product: Panafen Plus
Active Ingredients:

  • Codeine phosphate hemihydrate 12.8mg
  • Ibuprofen 200mg
    Dosage Form: Film coated tablet
    New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
    Manufacturer: GlaxoSmithKline Dungarvan Limited, Co. Waterford, Ireland

Dated this 29th day of September 2011.

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: Codalgin
Active Ingredients:

  • Codeine phosphate hemihydrate 8mg
  • Paracetamol 500mg
    Dosage Form: Tablet
    New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
    Manufacturer: Aspen Pharma Pty Limited, Dandenong, Australia

Product: Maximum Strength Mucinex (General Sale)
Active Ingredient: Guaifenesin 1200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers:

  • Catalent Pharma Solutions LLC, Kentucky, United States of America
  • Reckitt Benckiser Healthcare International Limited, Nottinghamshire, United Kingdom
  • Reckitt Benckiser LLC, Texas, United States of America

Product: Maximum Strength Mucinex (Restricted)
Active Ingredient: Guaifenesin 1200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers:

  • Catalent Pharma Solutions LLC, Kentucky, United States of America
  • Reckitt Benckiser Healthcare International Limited, Nottinghamshire, United Kingdom
  • Reckitt Benckiser LLC, Texas, United States of America


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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 150





✨ LLM interpretation of page content

🏥 Consent to Distribution of Menevit and Panafen Plus

🏥 Health & Social Welfare
29 September 2011
Medicines Act, New Medicines, Distribution Consent, Menevit, Panafen Plus
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Consent to Distribution of Codalgin and Maximum Strength Mucinex

🏥 Health & Social Welfare
Medicines Act, New Medicines, Distribution Consent, Codalgin, Maximum Strength Mucinex