Notice Type
Departmental
Notice Title

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: Clustran
Active Ingredients: Sumatriptan succinate 16.8mg/mL equivalent to sumatriptan 12mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: CARSL Consulting
Manufacturer: Sun Pharmaceutical Industries Limited, Halol, India
   
Product: Colofac
Active Ingredient: Mebeverine hydrochloride 135mg
Dosage Form: Tablet
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Laboratories SAS, Chatillon sur Charlaronne, France
   
Product: Eurax
Active Ingredient: Crotamiton 10%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Nice-Pak Products (NZ) Limited
Manufacturers: GSK Consumer Healthcare SARL, Prangins, Switzerland
Thornton & Ross Limited, Huddersfield, United Kingdom
   
Product: Gamunex
Active Ingredient: Normal immunoglobulin 100mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Grifols Therapeutics LLC, North Carolina, United States of America
   
Product: HyperHep B
Active Ingredient: Hepatitis B immunoglobulin, human 220IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Grifols Therapeutics LLC, North Carolina, United States of America
   
Product: Puregon
Active Ingredient: Follitropin beta 833IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Organon (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany


Dated this 14th day of January 2022.

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