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: Darzalex SC
Active Ingredient: Daratumumab 120mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
   
Product: Entresto 24/26
Active Ingredients: Sacubitril 24.3mg
Valsartan 25.7mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farma SpA, Torre Annunziata, Italy
Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore City, Singapore
   
Product: Entresto 49/51
Active Ingredients: Sacubitril 48.6mg
Valsartan 51.4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farma SpA, Torre Annunziata, Italy
Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore City, Singapore
   
Product: Entresto 97/103
Active Ingredients: Sacubitril 97.2mg
Valsartan 102.8mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farma SpA, Torre Annunziata, Italy
Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore City, Singapore
   
Product: Selsun Gold
Active Ingredient: Selenium sulfide 25mg/mL
Dosage Form: Shampoo
New Zealand Sponsor: Sanofi-Aventis New Zealand limited
Manufacturer: Tismor Health and Wellness Pty Limited, Sydney, Australia
   
Product: Shingrix
Active Ingredient: Recombinant varicella zoster virus glycoprotein E 50mcg
Dosage Form: Powder for injection
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Wavre, Belgium
Patheon Italia SpA, Milan, Italy
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France


Dated this 29th day of March 2022.

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