Notice Title

Provisional Consent to the Distribution of a New Medicine

Publication Date
24 Aug 2017

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2017-go4386

Issue Number

86
Title
View PDF
File Type and Size
PDF (21 KB)

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

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

Recombivax HB
Hepatitis B vaccine, rDNA 10mcg/mL
Suspension for injection
Merck Sharp & Dohme (New Zealand) Limited
Merck Sharp & Dohme Corp, Pennsylvania, United States of America

Note: This consent is given subject to the following conditions:

  • Provisional consent is subject to the following restriction: The medicine may only be marketed or distributed when no other hepatitis B vaccine with consent to distribute is available in the New Zealand market.

Also note: This consent is valid for one year from the date of publication of this notice.

Dated this 21st day of August 2017.

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