✨ Medicines Distribution Consent




27 JULY NEW ZEALAND GAZETTE 2035

Product: Zytram SR
Active Ingredient(s): Tramadol hydrochloride 200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom

Product: Zytram SR
Active Ingredient(s): Tramadol hydrochloride 75mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom

Product: Zytram XL
Active Ingredient(s): Tramadol hydrochloride 150mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom

Product: Zytram XL
Active Ingredient(s): Tramadol hydrochloride 200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom

Product: Zytram XL
Active Ingredient(s): Tramadol hydrochloride 300mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom

Product: Zytram XL
Active Ingredient(s): Tramadol hydrochloride 400mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Bard Pharmaceuticals Limited, Cambridge, United Kingdom

Dated this 19th day of July 2000.

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: Dysport
Active Ingredient(s): Clostridium botulinum type A toxin haemagglutinin complex 500U
Dosage Form: Powder for injection
New Zealand Sponsor: New Zealand Medical & Scientific Limited
Manufacturer(s): Ispen Limited, Clwyd, United Kingdom

Product: Singulair
Active Ingredient(s): Montelukast sodium 5.2mg equivalent to 5mg montelukast free acid
Dosage Form: Chewable tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2000, No 84


Gazette.govt.nz PDF NZ Gazette 2000, No 84





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
19 July 2000
Medicines, Distribution Consent, Tramadol hydrochloride, Zytram SR, Zytram XL
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
Medicines, Distribution Consent, Clostridium botulinum type A toxin, Montelukast sodium, Dysport, Singulair