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: | Duraphat Fluoride Varnish |
Active Ingredient: | Sodium fluoride 5%w/v |
Dosage Form: | Oral solution |
New Zealand Sponsor: | Colgate-Palmolive Limited (NZ) |
Manufacturer: | Pharbil Waltrop GmbH, Waltrop, Germany |
Product: | Kalydeco |
Active Ingredient: | Ivacaftor 150mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
Manufacturers: | Patheon Pharmaceuticals Inc, Ohio, United States of America Aesica Queenborough Limited, Queenborough, United Kingdom |
Product: | Keytruda |
Active Ingredient: | Pembrolizumab 25mg/mL |
Dosage Form: | Concentrate for infusion |
New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
Manufacturer: | MSD International GmbH t/a MSD Ireland (Carlow), Carlow, Ireland |
Product: | Keytruda |
Active Ingredient: | Pembrolizumab 50mg |
Dosage Form: | Powder for infusion |
New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
Manufacturer: | MSD International GmbH, Innishannon, Ireland |
Product: | Privigen |
Active Ingredient: | Normal immunoglobulin 100g/L |
Dosage Form: | Solution for infusion |
New Zealand Sponsor: | CSL Behring (NZ) Limited |
Manufacturers: | CSL Behring AG, Bern, Switzerland CSL Behring (Australia) Pty Limited, Melbourne, Australia |
Product: | Rydapt |
Active Ingredient: | Midostaurin 25mg |
Dosage Form: | Soft gelatin capsule |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Catalent Germany Eberbach GmbH, Eberbach, Germany |
Dated this 11th day of December 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).