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:

Clindamycin ABM

Active Ingredient:

Clindamycin hydrochloride 177.515mg equivalent to clindamycin 150mg

Dosage Form:

Capsule

New Zealand Sponsor:

Boucher & Muir (New Zealand) Limited t/a BNM Group

Manufacturer:

Chanelle Medical Limited, Loughrea, Ireland

   

Product:

Colgout

Active Ingredient:

Colchicine 0.5mg

Dosage Form:

Tablet

New Zealand Sponsor:

Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics

Manufacturers:

Strides Shasun Limited, Bangalore, India

Aspen Pharma Pty Limited, Melbourne, Australia

   

Product:

HBvaxPRO vaccine

Active Ingredient:

Hepatitis B vaccine, rDNA 10mcg/mL

Dosage Form:

Suspension for injection

New Zealand Sponsor:

Merck Sharp & Dohme (New Zealand) Limited

Manufacturer:

Merck Sharp & Dohme Corp, Pennsylvania, United States of America

   

Product:

HBvaxPRO vaccine

Active Ingredient:

Hepatitis B vaccine, rDNA 40mcg/mL

Dosage Form:

Suspension for injection

New Zealand Sponsor:

Merck Sharp & Dohme (New Zealand) Limited

Manufacturer:

Merck Sharp & Dohme Corp, Pennsylvania, United States of America


Dated this 25th day of July 2019.

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