✨ Medicines Distribution Consents




NEW ZEALAND GAZETTE, No. 136 β€” 6 NOVEMBER 2014

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

2014-go6779

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:
Levemir Flexpen
Active Ingredient:
Insulin detemir 100U/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturers:
Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Production SAS, Chartres Cedex, France
Novo Nordisk Producao Farmaceutica do Brasil Ltda, Minas Gerais, Brazil

Product:
Levemir Innolet
Active Ingredient:
Insulin detemir 100U/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturers:
Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Production SAS, Chartres Cedex, France

Product:
Levemir Penfill
Active Ingredient:
Insulin detemir 100U/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited
Manufacturers:
Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Production SAS, Chartres Cedex, France
Novo Nordisk Producao Farmaceutica do Brasil Ltda, Minas Gerais, Brazil

Dated this 31st day of October 2014.

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

2014-go6780

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:
Levothyroxine
Active Ingredient:
Levothyroxine sodium 0.1mg
Dosage Form:
Tablet
New Zealand Sponsor:
Boucher & Muir (NZ) Limited t/a Mercury Pharma (NZ)
Manufacturer:
Custom Pharmaceuticals Limited (UK), Sussex, United Kingdom

Note: This renewed consent is valid for two years from 11 November 2014.

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2014, No 136





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
31 October 2014
Medicines Act 1981, New Medicines, Distribution Consent, Pharmaceutical Products
  • Sarah Reader, Acting Group Manager, Medsafe, Ministry of Health

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

πŸ₯ Health & Social Welfare
Medicines Act 1981, Provisional Consent, Medicines Renewal, Pharmaceutical Products
  • Sarah Reader, Acting Group Manager, Medsafe, Ministry of Health