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).