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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: 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).