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).