✨ Medicines Distribution Consent




NEW ZEALAND GAZETTE, No. 144
22 SEPTEMBER 2011

Product: Cefazolin Pfizer
Active Ingredient: Cefazolin sodium 524mg equivalent to cefazolin 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India

Product: Cefazolin Pfizer
Active Ingredient: Cefazolin sodium 1048mg equivalent to cefazolin 1000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India

Product: Cefazolin Pfizer
Active Ingredient: Cefazolin sodium 2096mg equivalent to cefazolin 2000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Aurobindo Pharma Limited, Andhra Pradesh, India

Product: Deep Heat Arthritis Relief
Active Ingredients: Menthol 8%w/w
Methyl salicylate 30%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Ebos Group Limited
Manufacturer: Mentholatum Australasia Pty Limited, Scoresby, Australia

Product: Instillagel
Active Ingredients: Chlorhexidine gluconate 0.52mg/mL
Lidocaine hydrochloride, anhydrous 19.6mg/mL
Dosage Form: Topical gel
New Zealand Sponsor: MD Solutions NZ Limited
Manufacturer: Klosterfrau Berlin GmbH, Berlin, Germany

Product: Losartan HCTad
Active Ingredients: Hydrochlorothiazide 12.5mg
Losartan potassium 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: KRKA d d Novo mesto, Novo mesto, Slovenia

Dated this 15th 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 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: Dotarem (bottle)
Active Ingredient: Gadoteric acid 279.3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Obex Medical Limited
Manufacturers: Guerbet, Aulnay Sous Bois, France
Catalent Belgium SA, Brussels, Belgium

Product: Dotarem (syringe)
Active Ingredient: Gadoteric acid 279.32mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Obex Medical Limited
Manufacturers: Guerbet, Aulnay Sous Bois, France
Rovi Contract Manufacturing SL, Madrid, Spain
Catalent Belgium SA, Brussels, Belgium



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 144





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
15 September 2011
Medicines Act 1981, New medicines, Distribution consent, Pharmaceuticals
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health