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: Difflam Sore Throat Spray Anti-inflammatory
Active Ingredient: Benzydamine hydrochloride 1.5mg/mL
Dosage Form: Oral spray
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Aziende Chimiche Riunite Angelini Francesco SpA, Ancona, Italy
   
Product: Difflam Sore Throat Spray Anti-inflammatory Forte
Active Ingredient: Benzydamine hydrochloride 3mg/mL
Dosage Form: Oral spray
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Aziende Chimiche Riunite Angelini Francesco SpA, Ancona, Italy
   
Product: Erlyand
Active Ingredient: Apalutamide 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
   
Product: Kisqali
Active Ingredient: Ribociclib succinate 254.4mg equivalent to ribociclib 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore City, Singapore
   
Product: Simbrinza
Active Ingredients: Brimonidine tartrate 2mg/mL
Brinzolamide 10mg/mL
Dosage Form: Eye drops, suspension
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Alcon Couvreur NV, Puurs, Belgium
   
Product: Tivicay
Active Ingredient: Dolutegravir sodium 52.6mg equivalent to dolutegravir 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturers: Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Hertfordshire, United Kingdom
GlaxoSmithKline Pharmaceuticals SA, Poznan, Poland
   
Product: Voltaren D
Active Ingredient: Diclofenac 46.5mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Schaffhauserstrasse, Switzerland
Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey


Dated this 6th day of September 2021.

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