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).