✨ Medicines Act Notices




31 JANUARY NEW ZEALAND GAZETTE 251

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 set out in the Schedule hereto:

Schedule

Product: Avelox IV 400
Active Ingredient: Moxifloxacin hydrochloride 436.8mg equivalent to 400mg moxifloxacin
Dosage Form: Solution for infusion
New Zealand Sponsor: Bayer New Zealand Limited Health Care Division
Manufacturer: Bayer AG, Bayerwerk, Leverkusen 1, Germany

Product: Difflam-C Anti-inflammatory Antiseptic Solution
Active Ingredient(s): Benzydamine hydrochloride 0.15%w/v
Chlorhexidine gluconate 0.12%w/v
Dosage Form: Mouthwash
New Zealand Sponsor: 3M Pharmaceuticals (a division of 3M New Zealand Limited)
Manufacturer: 3M Pharmaceuticals (Australia) Pty Limited, Thornleigh, New South Wales, Australia

Product: Enbrel
Active Ingredient: Etanercept 25mg
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany

Product: Enbrel
Active Ingredient: Etanercept 25mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany

Dated this 23rd day of January 2002.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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Consent to the Distribution of Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Twinrix Junior
Active Ingredient(s): Hepatitis A vaccine 720EU/mL
Hepatitis B surface antigen (recombinant) 20Β΅g/mL
Dosage Form: 0.5mL Suspension for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium

Product: Twinrix
Active Ingredient(s): Hepatitis A vaccine 720EU/mL
Hepatitis B surface antigen (recombinant) 20Β΅g/mL
Dosage Form: 1mL Suspension for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals SA, Rixensart, Belgium

Dated this 23rd day of January 2002.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2002, No 9


Gazette.govt.nz PDF NZ Gazette 2002, No 9





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
23 January 2002
Medicines Act, New Medicines, Distribution Consent
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
23 January 2002
Medicines Act, Changed Medicines, Distribution Consent
  • G. R. Boyd, Chief Advisor, Safety and Regulation