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:

Arrow - Tranexamic Acid
Tranexamic acid 100mg/mL
Solution for injection
Actavis New Zealand Limited
Gland Pharma Limited, Andhara Pradesh, India

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

Giotrif
Afatinib dimaleate 29.56mg equivalent to Afatinib 20mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

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

Giotrif
Afatinib dimaleate 44.34mg equivalent to Afatinib 30mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredient:
Dosage Form:

New Zealand Sponsor:
Manufacturer:

Giotrif
Afatinib dimaleate 59.12mg equivalent to Afatinib 40mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

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

Giotrif
Afatinib dimaleate 73.9mg equivalent to Afatinib 50mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Harvoni
Ledipasvir 90mg
Sofosbuvir 400mg
Film coated tablet
Gilead Sciences (NZ)
Gilead Sciences Limited, County Cork, Ireland
Patheon Inc, Ontario, Canada

Product:
Active Ingredient:
Dosage Form:

New ZealandSponsor:
Manufacturer:

Montelukast Mylan
Montelukast sodium 4.15mg equivalent to Montelukast 4mg
Chewable tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

Product:
Active Ingredient:
Dosage Form:

New Zealand Sponsor:
Manufacturer:

Montelukast Mylan
Montelukast sodium 5.19mg equivalent to Montelukast 5mg
Chewable tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

Dated this 31st day of October 2014.

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