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: Benzatropine Injection
Active Ingredient: Benzatropine mesilate 1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Phebra NZ Limited
Manufacturer: Phebra Pty Limited, Sydney, Australia
   
Product: Capecitabine Mylan
Active Ingredient: Capecitabine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
   
Product: Capecitabine Mylan
Active Ingredient: Capecitabine 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
   
Product: Teicoplanin Multichem
Active Ingredient: Teicoplanin 400mg equivalent to NLT 400,000 IU. 10% overage included.
Dosage Form: Powder for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA Pharmaceutical Industry, Athens, Greece


Dated this 27th day of September 2019.

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