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: 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).