✨ Medicines Consent Notices




2722 NEW ZEALAND GAZETTE, No. 96 21 AUGUST 2014

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: Apo-Leflunomide
Active Ingredient: Leflunomide 10mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada

Product: Apo-Leflunomide
Active Ingredient: Leflunomide 20mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada

Dated this 15th day of August 2014.

SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

go5156

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product: Sodibic
Active Ingredient: Sodium bicarbonate 840mg
Dosage Form: Capsule
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Strides Arcolab Limited, Bangalore, India

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 15th day of August 2014.

SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

go5157

Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:

Schedule

Product: Fentanyl
Active Ingredient: Fentanyl citrate 15.71mg/L equivalent to Fentanyl 10mg/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand

Note: This renewed consent is valid for two years from 23 September 2014.

Product: Fentanyl
Active Ingredient: Fentanyl citrate 31.42mg/L equivalent to Fentanyl 20mg/L
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand

Note: This renewed consent is valid for two years from 23 September 2014.

Product: Mitomycin for Injection
Active Ingredient: Mitomycin 5mg
Dosage Form: Powder for injection
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India

Note: This renewed consent is valid for two years from 28 October 2014.



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2014, No 96





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
15 August 2014
Medicines, Distribution, Consent, Leflunomide
  • SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
15 August 2014
Medicines, Provisional Consent, Sodium Bicarbonate
  • SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of Medicines

πŸ₯ Health & Social Welfare
15 August 2014
Medicines, Renewal of Provisional Consent, Fentanyl, Mitomycin
  • SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health