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).