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: Dasatinib-Teva
Active Ingredient: Dasatinib monohydrate 20.739mg equivalent to dasatinib 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia
   
Product: Dasatinib-Teva
Active Ingredient: Dasatinib monohydrate 51.847mg equivalent to dasatinib 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia
   
Product: Dasatinib-Teva
Active Ingredient: Dasatinib monohydrate 72.585mg equivalent to dasatinib 70mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia
   
Product: Dasatinib-Teva
Active Ingredient: Dasatinib monohydrate 103.693mg equivalent to dasatinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: PLIVA Croatia Limited, Zagreb, Croatia
   
Product: Gutron
Active Ingredient: Midodrine hydrochloride 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Takeda GmbH, Oranienburg, Germany
   
Product: Gutron
Active Ingredient: Midodrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Takeda GmbH, Oranienburg, Germany


Dated this 9th day of April 2021.

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