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:
Manufacturer:

Catapres-TTS
Clonidine 2.5mg
Transdermal patch
Boehringer Ingelheim (NZ) Limited
Alza Corporation, California, United States of America

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

Catapres-TTS
Clonidine 5mg
Transdermal patch
Boehringer Ingelheim (NZ) Limited
Alza Corporation, California, United States of America

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

Catapres-TTS
Clonidine 7.5mg
Transdermal patch
Boehringer Ingelheim (NZ) Limited
Alza Corporation, California, United States of America

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturer:

Duolin
Ipratropium bromide monohydrate 0.021mg
equivalent to Ipratropium bromide anhydrous 0.020mg;
Salbutamol sulfate 0.12mg equivalent to Salbutamol 0.100mg
Aerosol inhaler, metered dose
REX Medical Limited
Cipla Limited, Goa, India

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

Eliquis
Apixaban 2.5mg
Film coated tablet
Pfizer New Zealand Limited
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico

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

Eliquis
Apixaban 5mg
Film coated tablet
Pfizer New Zealand Limited
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico

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

Priligy
Dapoxetine hydrochloride 33.6mg equivalent to Dapoxetine 30mg
Film coated tablet
Te Arai Biofarma Limited
Janssen Ortho LLC, Gurabo, Puerto Rico
Menarini – Von Heyden GmbH, Dresden, Germany

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

Priligy
Dapoxetine hydrochloride 67.2mg equivalent to Dapoxetine 60mg
Film coated tablet
Te Arai Biofarma Limited
Janssen Ortho LLC, Gurabo, Puerto Rico
Menarini Von Heyden GmbH, Dresden, Germany

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

Xolair
Omalizumab 75mg
Injection with diluent
Novartis New Zealand Limited
Genentech Inc, California, United States of America
Novartis Pharma Stein AG, Stein, Switzerland

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

Xolair
Omalizumab 150mg
Injection with diluent
Novartis New Zealand Limited
Genentech Inc, California, United States of America
Novartis Pharma Stein AG, Stein, Switzerland

Dated this 23rd day of July 2015.

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