✨ Medicines Distribution Consents




3 DECEMBER 2009 NEW ZEALAND GAZETTE, No. 178 4325

Medicines Act 1981

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: Mirena
Active Ingredient: Levonorgestrel 52mg
Dosage Form: Intrauterine contraceptive device
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Schering Pharma Oy, Turku, Finland

Dated this 25th day of November 2009.

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, 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: Anapen
Active Ingredient: Adrenaline 1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Link Pharmaceuticals Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Product: Anapen Junior
Active Ingredient: Adrenaline 500Β΅g/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Link Pharmaceuticals Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Product: Apo-Clomipramine
Active Ingredient: Clomipramine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada

Product: Aspirin
Active Ingredient: Aspirin 300mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Manufacturing Division, Taluka - Daund, District - Pune, Maharashtra State, India

Product: Irinotecan Actavis 100
Active Ingredient: Irinotecan hydrochloride 100mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma Srl, Bucharest, Romania

Product: Irinotecan Actavis 40
Active Ingredient: Irinotecan hydrochloride 40mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma Srl, Bucharest, Romania

Product: Laxofast 120
Active Ingredient: Docusate sodium 120mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Softgel Healthcare Pvt. Limited, Kancheepuram District, Tamilnadu, India



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2009, No 178





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of a New Medicine (Mirena)

πŸ₯ Health & Social Welfare
25 November 2009
Medicines Act, Consent, Distribution, Mirena, Levonorgestrel, Intrauterine contraceptive device
  • STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
25 November 2009
Medicines Act, Consent, Distribution, Anapen, Anapen Junior, Apo-Clomipramine, Aspirin, Irinotecan Actavis 100, Irinotecan Actavis 40, Laxofast 120
  • STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health