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 set out in the Schedule hereto:

Schedule

Product: Fluad Quad
Active Ingredients: Influenza virus A/Brisbane/02/2018 (H1N1) pdm09-like virus 15mcg
Influenza virus A/South Australia/34/2019 (H3N2)-like virus 15mcg
Influenza virus B/Phuket/3073/2013 - like strain 15mcg
Influenza virus B/Washington/02/2019-like (B/Victoria lineage) virus 15mcg
Dosage Form: Suspension for injection
New Zealand Sponsor: Seqirus (NZ) Limited
Manufacturer: Seqirus Inc., North Carolina, United States of America
   
Product: Kalydeco
Active Ingredient: Ivacaftor 50mg
Dosage Form: Oral granules
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Halo Pharmaceutical Inc, New Jersey, United States of America
Almac Pharma Services Limited, Craigavon, United Kingdom
   
Product: Kalydeco
Active Ingredient: Ivacaftor 75mg
Dosage Form: Oral granules
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Halo Pharmaceutical Inc, New Jersey, United States of America
Almac Pharma Services Limited, Craigavon, United Kingdom
   
Product: Panadol Mini Caps (GSK) (General sale)
Active Ingredient: Paracetamol 500mg
Dosage Form: Coated tablet
New Zealand Sponsor: GlaxoSmithKline Consumer Healthcare New Zealand ULC
Manufacturer: GlaxoSmithKline Australia Pty Limited, Sydney, Australia
   
Product: Panadol Mini Caps (GSK) (Pharmacy only)
Active Ingredient: Paracetamol 500mg
Dosage Form: Coated tablet
New Zealand Sponsor: GlaxoSmithKline Consumer Healthcare New Zealand ULC
Manufacturer: GlaxoSmithKline Australia Pty Limited, Sydney, Australia


Dated this 11th day of December 2020.

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