Notice Type
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:




Active Ingredients:

Diphtheria toxoid, adsorbed 30Lf U equivalent to not less than 20IU

Haemophilus influenzae type b polysaccharide 12mcg

Hepatitis B virus surface antigen 10mcg

Pertussis filamentous haemagglutinin 25mcg

Pertussis toxoid, adsorbed 25mcg

Polio virus type 1 40DAgU

Polio virus type 2 8DAgU

Polio virus type 3 32DAgU

Tetanus toxoid, adsorbed 10Lf U equivalent to not less than 40IU

Dosage Form:

Suspension for injection

New Zealand Sponsor:

Sanofi-Aventis New Zealand Limited


Sanofi Pasteur SA, Marcy L'Etoile, France

Sanofi Pasteur SA, Val-De-Reuil Cedex, France



Active Ingredient:

Salcatonin 100IU/mL

Dosage Form:

Solution for injection

New Zealand Sponsor:

Emerge Health New Zealand Limited


Novartis Pharma Stein AG, Stein, Switzerland

Solupharm Pharmaceutical Products GmbH & Co. KG, Melsungen, Germany



Active Ingredient:

Propafenone hydrochloride 150mg

Dosage Form:


New Zealand Sponsor:

Mylan New Zealand Limited


Famar Lyon, Saint-Genis-Laval, France

Mylan Laboratories Limited, Aurangabad, India

Dated this 18th day of May 2021.

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