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:
Product: | Brenzys (Pre-filled Pen) |
Active Ingredient: | Etanercept 50mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Samsung Bioepis NZ Limited |
Manufacturers: | Catalent Belgium SA, Brussels, Belgium Patheon Italia SpA, Milan, Italy |
Product: | Brenzys (Pre-filled Syringe) |
Active Ingredient: | Etanercept 50mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Samsung Bioepis NZ Limited |
Manufacturers: | Catalent Belgium SA, Brussels, Belgium Patheon Italia SpA, Milan, Italy |
Product: | Canesoral Duo (Combination Product) |
Active Ingredient: | Fluconazole 150mg |
Dosage Form: | Capsule |
Active Ingredient: | Clotrimazole 10mg/g |
Dosage Form: | Topical cream |
New Zealand Sponsor: | Bayer New Zealand Limited |
Manufacturers: | Intas Pharmaceuticals Ltd, Ahmedabad, India Kern Pharma SL, Barcelona, Spain Encube Ethicals Private Limited, Ponda, India GP Grenzach Produktions GmbH, Grenzach-Wyhlen, Germany |
Product: | Canesten |
Active Ingredient: | Clotrimazole 1%w/w |
Dosage Form: | Topical cream |
New Zealand Sponsor: | Bayer New Zealand Limited |
Manufacturers: | Kern Pharma SL, Barcelona, Spain Encube Ethicals Private Limited, Ponda, India GP Grenzach Produktions GmbH, Grenzach-Wyhlen, Germany |
Product: | Canesten Clotrimazole Thrush 1 Day Pessary & Cream (Combination Product) |
Active Ingredient: | Clotrimazole 500mg |
Dosage Form: | Vaginal tablet |
Active Ingredient: | Clotrimazole 1%w/w |
Dosage Form: | Topical cream |
New Zealand Sponsor: | Bayer New Zealand Limited |
Manufacturers: | Kern Pharma SL, Barcelona, Spain Bayer AG, Leverkusen, Germany Encube Ethicals Private Limited, Ponda, India Haupt Pharma Wulfing GmbH, Gronau/Leine, Germany GP Grenzach Produktions GmbH, Grenzach-Wyhlen, Germany |
Product: | Canesten Clotrimazole Thrush 6 Day Cream |
Active Ingredient: | Clotrimazole 1%w/w |
Dosage Form: | Vaginal cream |
New Zealand Sponsor: | Bayer New Zealand Limited |
Manufacturers: | Kern Pharma SL, Barcelona, Spain Encube Ethicals Private Limited, Ponda, India GP Grenzach Produktions GmbH, Grenzach-Wyhlen, Germany |
Product: | Tamiflu |
Active Ingredient: | Oseltamivir phosphate 39.4mg/g equivalent to oseltamivir 6mg/mL when reconstituted with 55mL of water |
Dosage Form: | Powder for oral suspension |
New Zealand Sponsor: | Roche Products (NZ) Ltd |
Manufacturer: | Rottendorf Pharma GmbH, Ennigerloh, Germany |
Product: | Tamiflu |
Active Ingredient: | Oseltamivir phosphate 39.4mg equivalent to oseltamivir 30mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Roche Products (NZ) Ltd |
Manufacturers: | Delpharm Milano S.r.L, Milan, Italy Patheon Manufacturing Services LLC, North Carolina, United States of America |
Product: | Tamiflu |
Active Ingredient: | Oseltamivir phosphate 59.1mg equivalent to oseltamivir 45mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Roche Products (NZ) Ltd |
Manufacturers: | Delpharm Milano S.r.L, Milan, Italy Patheon Manufacturing Services LLC, North Carolina, United States of America |
Product: | Tamiflu |
Active Ingredient: | Oseltamivir phosphate 98.5mg equivalent to oseltamivir 75mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Roche Products (NZ) Ltd |
Manufacturers: | Cenexi SAS, Fontenay-sous-Bois, France Catalent Germany Schorndorf GmbH, Schorndorf, Germany Delpharm Milano S.r.L, Milan, Italy |
Product: | Varivax |
Active Ingredient: | Varicella vaccine 1350PFU |
Dosage Form: | Suspension for injection with diluent |
New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
Manufacturers: | Merck Sharp & Dohme Corp, Pennsylvania, United States of America Merck Sharp & Dohme Corp, North Carolina, United States of America |
Dated this 19th day of January 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).