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:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Enstilar
Betamethasone dipropionate 643mcg/g equivalent to betamethasone 500mcg/g
Calcipotriol monohydrate 52.2mcg/g equivalent to calcipotriol 50mcg/g
Foam
LEO Pharma Limited
LEO Laboratories Limited, Dublin, Ireland
Colep Laupheim GmbH & Co KG, Laupheim, Germany
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Glytrin
Glyceryl trinitrate 400mcg/dose
Sublingual spray
AFT Pharmaceuticals Limited
Pharmasol (UK) Limited, Andover, United Kingdom
Pharmaserve (North West) Limited, Runcorn, United Kingdom
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Keytruda
Pembrolizumab 25mg/mL
Concentrate for infusion
Merck Sharp & Dohme (New Zealand) Limited
MSD International GmbH (Ireland), Carlow, Ireland
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Keytruda
Pembrolizumab 50mg
Powder for infusion
Merck Sharp & Dohme (New Zealand) Limited
MSD International GmbH, Innishannon, Ireland
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Tecentriq
Atezolizumab 1200mg
Concentrate for infusion
Roche Products (NZ) Limited
Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
|
Note: The application received 15 November 2018 is for the new indication for treatment of extensive-stage small cell lung cancer (ES-SCLC).
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Tecentriq
Atezolizumab 1200mg
Concentrate for infusion
Roche Products (NZ) Limited
Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
|
Note: The application received 20 April 2018 is for the new indication for first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC).
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Venclexta
Venetoclax 10mg
Film coated tablet
AbbVie Limited
AbbVie Ireland NL B.V., Sligo, Ireland
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Venclexta
Venetoclax 50mg
Film coated tablet
AbbVie Limited
AbbVie Ireland NL B.V., Sligo, Ireland
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Venclexta
Venetoclax 100mg
Film coated tablet
AbbVie Limited
AbbVie Ireland NL B.V., Sligo, Ireland
|
|
Product:
Component 1:
Active Ingredient:
Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:
Component 3:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Venclexta
Venetoclax 10mg
Film coated tablet
Venetoclax 50mg
Film coated tablet
Venetoclax 100mg
Film coated tablet
AbbVie Limited
AbbVie Ireland NL B.V., Sligo, Ireland
|
Dated this 20th day of May 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz