✨ Medicines Distribution Consents
1794 NEW ZEALAND GAZETTE, No. 76 2 JUNE 2011
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Laboratorio Reig Jofre SA, Barcelona, Spain
Product: Remifentanil-AFT
Active Ingredient: Remifentanil hydrochloride 2.194mg equivalent to remifentanil 2mg
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Laboratorio Reig Jofre SA, Barcelona, Spain
Product: Remifentanil-AFT
Active Ingredient: Remifentanil hydrochloride 5.485mg equivalent to remifentanil 5mg
Dosage Form: Powder for injection
Dated this 26th day of May 2011.
PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).
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Renewal of Provisional Consent to the Distribution of a Medicine
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 medicine set out in the Schedule hereto:
Schedule
Product: Tykerb
Active Ingredient: Lapatinib ditosilate 405mg equivalent to Lapatinib free base 250mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
Note: This renewed consent is valid for two years from 23 August 2011.
Dated this 26th day of May 2011.
PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, 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 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: Cymbalta
Active Ingredient: Duloxetine hydrochloride 33.7mg equivalent to duloxetine base 30mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Eli Lilly and Co Inc, Indiana, United States of America
Product: Cymbalta
Active Ingredient: Duloxetine hydrochloride 67.3mg equivalent to duloxetine base 60mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Eli Lilly and Co Inc, Indiana, United States of America
Product: Estrofem
Active Ingredient: Oestradiol hemihydrate 1.03mg
Dosage Form: Tablet
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Måløv, Denmark
Product: Estrofem
Active Ingredient: Oestradiol hemihydrate 2.07mg
Dosage Form: Tablet
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Måløv, Denmark
Product: Humalog (Cartridge)
Active Ingredient: Insulin lispro 100U/mL
Dosage Form: Solution for injection
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✨ LLM interpretation of page content
🏥
Consent to the Distribution of New Medicines
(continued from previous page)
🏥 Health & Social Welfare26 May 2011
Medicines Act, New Medicines, Remifentanil-AFT
- PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
🏥 Renewal of Provisional Consent to the Distribution of a Medicine
🏥 Health & Social Welfare26 May 2011
Medicines Act, Renewal, Tykerb
- PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
🏥 Consent to the Distribution of New Medicines
🏥 Health & Social Welfare26 May 2011
Medicines Act, New Medicines, Cymbalta, Estrofem, Humalog
- PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
NZ Gazette 2011, No 76