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: Duavive
Active Ingredients: Bazedoxifene acetate 22.56mg equivalent to bazedoxifene 20mg
Conjugated estrogens 0.45mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Ireland Pharmaceuticals, Newbridge, Ireland
   
Product: PIQRAY
Active Ingredient: Alpelisib 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
   
Product: PIQRAY
Component 1:  
Active Ingredient: Alpelisib 50mg
Dosage Form: Film coated tablet
Component 2:  
Active Ingredient: Alpelisib 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
   
Product: PIQRAY
Active Ingredient: Alpelisib 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland


Dated this 27th day of May 2024.

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