Medicines Distribution Consent




14 APRIL 2011 NEW ZEALAND GAZETTE, No. 51 1185

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: Listerine Total Care Antiseptic Mouthwash, Clean Mint Flavour
Active Ingredients:

  • Benzoic acid 0.12%w/v
  • Cineole 0.092%w/v
  • Ethanol 18.096%w/v
  • Sodium fluoride 0.0221%w/v
  • Thymol 0.064%w/v
  • Zinc chloride 0.09%w/v
    Dosage Form: Mouthwash
    New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
    Manufacturer: IDS Manufacturing Limited, Pathumthani, Thailand

Product: Tasigna
Active Ingredient: Nilotinib hydrochloride monohydrate 165.45mg equivalent to nilotinib anhydrous free base 150mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: Your Pharmacy Double Strength Paracetamol Suspension
Active Ingredient: Paracetamol 4.167%w/w
Dosage Form: Oral suspension
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

Product: Your Pharmacy Pain Relief
Active Ingredients:

  • Codeine phosphate hemihydrate 10mg
  • Paracetamol 500mg
    Dosage Form: Tablet
    New Zealand Sponsor: Orion Laboratories (NZ) Limited
    Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

Dated this 7th day of April 2011.

MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation, 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: Synflorix
Active Ingredients:

  • Pneumococcal Polysaccharide type 1 1μg
  • Pneumococcal Polysaccharide type 14 1μg
  • Pneumococcal Polysaccharide type 18C 3μg
  • Pneumococcal Polysaccharide type 19F 3μg
  • Pneumococcal Polysaccharide type 23F 1μg
  • Pneumococcal Polysaccharide type 4 3μg
  • Pneumococcal Polysaccharide type 5 1μg
  • Pneumococcal Polysaccharide type 6B 1μg
  • Pneumococcal Polysaccharide type 7F 1μg
  • Pneumococcal Polysaccharide type 9V 1μg
    Dosage Form: Suspension for injection
    New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
    Manufacturers:
  • GlaxoSmithKline Biologicals SA, Rixensart, Belgium
  • GlaxoSmithKline Biologicals SA, Wavre, Belgium

Dated this 7th day of April 2011.

MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 51





✨ LLM interpretation of page content

🏥 Consent to Distribution of New Medicines

🏥 Health & Social Welfare
7 April 2011
Medicines Act 1981, Listerine Total Care, Tasigna, Your Pharmacy Paracetamol, Your Pharmacy Pain Relief
  • MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation, Ministry of Health

🏥 Consent to Distribution of a New Medicine

🏥 Health & Social Welfare
7 April 2011
Medicines Act 1981, Synflorix
  • MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation, Ministry of Health