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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Apo-Azathioprine
Azathioprine 25mg
Film coated tablet
Apotex NZ Limited
RPG Life Sciences Limited, Gujarat, India

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Apo-Azathioprine
Azathioprine 50mg
Film coated tablet
Apotex NZ Limited
RPG Life Sciences Limited, Gujarat, India

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Mekinist
Trametinib dimethyl sulfoxide 0.5635mg equivalent to Trametinib 0.5mg
Film coated tablet
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Manufacturing SpA, Parma, Italy

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Mekinist
Trametinib dimethyl sulfoxide 1.127mg equivalent to Trametinib 1mg
Film coated tablet
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Manufacturing SpA, Parma, Italy

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Mekinist
Trametinib dimethyl sulfoxide 2.254mg equivalent to Trametinib 2mg
Film coated tablet
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Manufacturing SpA, Parma, Italy

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

PipTaz-AFT
Piperacillin monohydrate 4000mg
Tazobactam 500mg
Powder for injection
AFT Pharmaceuticals Limited
Qilu Tianhe Pharmaceutical Co Limited, Shandong Province, China

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Piramal Sevoflurane
Sevoflurane 100%v/v
Volatile liquid for inhalation
Device Technologies New Zealand
Piramal Critical Care Inc, Pennsylvania, United States of America

Dated this 20th day of March 2015.

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