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 set out in the Schedule hereto:

Schedule

Product: Aimovig (Pen)
Active Ingredient: Erenumab 140mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Amgen Manufacturing Limited, Juncos, Puerto Rico
   
Product: Aimovig (Syringe)
Active Ingredient: Erenumab 140mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Amgen Manufacturing Limited, Juncos, Puerto Rico
   
Product: Ibuprofen (Health Direct)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Geltec Private Limited, Attibele, India
   
Product: Numit
Active Ingredients: Lidocaine 2.5%w/w
Prilocaine 2.5%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ego Pharmaceuticals Pty Limited, Melbourne, Australia
   
Product: Rosuvastatin Dr.Reddy’s
Active Ingredient: Rosuvastatin calcium 5.2mg equivalent to rosuvastatin 5mg
Dosage Form: Tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
   
Product: Rosuvastatin Dr.Reddy’s
Active Ingredient: Rosuvastatin calcium 10.4mg equivalent to rosuvastatin 10mg
Dosage Form: Tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
   
Product: Rosuvastatin Dr.Reddy’s
Active Ingredient: Rosuvastatin calcium 20.8mg equivalent to rosuvastatin 20mg
Dosage Form: Tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
   
Product: Rosuvastatin Dr.Reddy’s
Active Ingredient: Rosuvastatin calcium 41.6mg equivalent to rosuvastatin 40mg
Dosage Form: Tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
   
Product: Teriparatide BNM
Active Ingredient: Teriparatide 0.25mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturers: Recipharm Monts SAS, Monts, France
BCN Peptides SA, Barcelona, Spain
   
Product: Trikafta 50/25/37.5
Component 1:  
Active Ingredients: Elexacaftor 50mg
Ivacaftor 37.5mg
Tezacaftor 25mg
Dosage Form: Film coated tablet
Component 2:  
Active Ingredient: Ivacaftor 75mg
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
Vertex Pharmaceutical Incorporated, Massachusetts, United States of America
   
Product: Trikafta 100/50/75
Component 1:  
Active Ingredients: Elexacaftor 100mg
Ivacaftor 75mg
Tezacaftor 50mg
Dosage Form: Film coated tablet
Component 2:  
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
Vertex Pharmaceutical Incorporated, Massachusetts, United States of America
   
Product: Trientine Waymade
Active Ingredient: Trientine dihydrochloride 250mg
Dosage Form: Capsule
New Zealand Sponsor: Clinect NZ Pty Limited
Manufacturer: Apothecon Pharmaceuticals Pvt. Limited, Vadodara, India
   
Product: Zirabev
Active Ingredient: Bevacizumab 25mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pharmacia & Upjohn Company LLC, Michigan, United States of America


Dated this 6th day of December 2021.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).