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: Glycopyrrolate Indoco
Active Ingredient: Glycopyrronium bromide 0.2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Miro Healthcare Limited
Manufacturer: Indoco Remedies Limited, Verna, India
   
Product: Tukysa
Active Ingredient: Tucatinib 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Corden Pharma GmbH, Plankstadt, Germany
   
Product: Tukysa
Active Ingredient: Tucatinib 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Corden Pharma GmbH, Plankstadt, Germany
   
Product: Verdye
Active Ingredient: Indocyanine green 25mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Patheon Italia S.p.A, Milan, Italy


Dated this 3rd day of November 2023.

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