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).