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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

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

Copaxone
Glatiramer acetate 20mg
Solution for injection
Teva Pharma (New Zealand) Limited
Teva Pharmaceutical Industries Limited, Kfar Saba, Israel
IVAX Pharmaceuticals UK Limited, Runcorn, United Kingdom

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

Copaxone
Glatiramer acetate 40mg
Solution for injection
Teva Pharma (New Zealand) Limited
IVAX Pharmaceuticals UK Limited, Runcorn, United Kingdom
Teva Pharmaceutical Industries Limited, Kfar Saba, Israel

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturers:

Maviret
Glecaprevir 100mg
Pibrentasvir 40mg
Film coated tablet
AbbVie Limited
AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany
Fournier Laboratories Ireland Limited, Carrigtwohill, Ireland

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

Robitussin Chesty Cough
Guaifenesin 20mg/mL
Oral solution
Pfizer New Zealand Limited
Interphil Laboratories Inc, Cabuyao, Philippines

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturers:

Robitussin Chesty Cough & Nasal Congestion PE
Guaifenesin 20mg/mL
Phenylephrine hydrochloride 1mg/mL
Oral solution
Pfizer New Zealand Limited
Fareva Richmond Inc, Virginia, United States of America
Olic (Thailand) Limited, Ayutthaya, Thailand

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Robitussin Chesty Cough Forte
Bromhexine hydrochloride 0.8mg/mL
Guaifenesin 20mg/mL
Oral solution
Pfizer New Zealand Limited
Interphil Laboratories Inc, Cabuyao, Philippines

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Robitussin Mucus Relief Double Action
Bromhexine hydrochloride 0.8mg/mL
Guaifenesin 20mg/mL
Oral solution
Pfizer New Zealand Limited
Interphil Laboratories Inc, Cabuyao, Philippines

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Trajentamet
Linagliptin 2.5mg
Metformin hydrochloride 500mg
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:
Manufacturer:

Trajentamet
Linagliptin 2.5mg
Metformin hydrochloride 850mg
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:
Manufacturer:

Trajentamet
Linagliptin 2.5mg
Metformin hydrochloride 1000mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Dated this 14th day of June 2019.

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