Notice Title

Consent to the Distribution of New Medicines

Publication Date
27 Nov 2024

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2024-go6067
Title
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File Type and Size
PDF (39 KB)

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: Alcaine
Active Ingredient: Proxymetacaine hydrochloride 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon Laboratories (New Zealand) Limited
Manufacturers: Alcon Couvreur NV, Puurs, Belgium
Alcon Research LLC, Texas, United States of America
   
Product: Entresto 24/26
Active Ingredient: Sacubitril/valsartan 50mg equivalent to sacubitril 24.3mg and valsartan 25.7mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Farma SpA, Torre Annunziata, Italy
Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey
Novartis Singapore Pharmaceutical Manufacturing Pte Ltd, Singapore
   
Product: Entresto 49/51
Active Ingredient: Sacubitril/valsartan 100g equivalent to sacubitril 48.6mg and valsartan 51.4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Farma SpA, Torre Annunziata, Italy
Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey
Novartis Singapore Pharmaceutical Manufacturing Pte Ltd, Singapore
   
Product: Entresto 97/103
Active Ingredient: Sacubitril/valsartan 200mg equivalent to sacubitril 97.2mg and valsartan 102.8mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Farma SpA, Torre Annunziata, Italy
Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey
Novartis Singapore Pharmaceutical Manufacturing Pte Ltd, Singapore
   
Product: Tenofovir Disoproxil Emtricitabine Efavirenz Viatris
Active Ingredients: Efavirenz 600mg
Emtricitabine 200mg
Tenofovir disoproxil maleate 300mg equivalent to 245mg Tenofovir disoproxil
Dosage Form: Film coated tablet
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Laboratories Limited, Pithampur, India
   
Product: Tenofovir Disoproxil Emtricitabine Viatris
Active Ingredient: Emtricitabine 200mg
Tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Laboratories Limited, Pithampur, India
   
Product: Trajenta
Active Ingredient: Linagliptin 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany
West-Ward Columbus Inc., Ohio, United States of America


Dated this 25th day of November 2024.

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