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: | Azacitidine Accord |
Active Ingredient: | Azacitidine 100mg |
Dosage Form: | Powder for injection |
New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
Manufacturer: | Intas Pharmaceuticals Limited, Ahmedabad, India |
Product: | Buvidal Monthly (64mg/0.18mL) |
Active Ingredient: | Buprenorphine 356mg/mL |
Dosage Form: | Injection (depot) |
New Zealand Sponsor: | CARSL Consulting |
Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
Product: | Buvidal Monthly (96mg/0.27mL) |
Active Ingredient: | Buprenorphine 356mg/mL |
Dosage Form: | Injection (depot) |
New Zealand Sponsor: | CARSL Consulting |
Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
Product: | Buvidal Monthly (128mg/0.36mL) |
Active Ingredient: | Buprenorphine 356mg/mL |
Dosage Form: | Injection (depot) |
New Zealand Sponsor: | CARSL Consulting |
Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
Product: | Buvidal Weekly (8mg/0.16mL) |
Active Ingredient: | Buprenorphine 50mg/mL |
Dosage Form: | Injection (depot) |
New Zealand Sponsor: | CARSL Consulting |
Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
Product: | Buvidal Weekly (16mg/0.32mL) |
Active Ingredient: | Buprenorphine 50mg/mL |
Dosage Form: | Injection (depot) |
New Zealand Sponsor: | CARSL Consulting |
Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
Product: | Buvidal Weekly (24mg/0.48mL) |
Active Ingredient: | Buprenorphine 50mg/mL |
Dosage Form: | Injection (depot) |
New Zealand Sponsor: | CARSL Consulting |
Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
Product: | Buvidal Weekly (32mg/0.64mL) |
Active Ingredient: | Buprenorphine 50mg/mL |
Dosage Form: | Injection (depot) |
New Zealand Sponsor: | CARSL Consulting |
Manufacturer: | Rechon Life Science AB, Limhamn, Sweden |
Product: | Nexium 24HR Once Daily Dosing |
Active Ingredient: | Esomeprazole magnesium trihydrate 22.3mg equivalent to esomeprazole 20mg |
Dosage Form: | Enteric coated tablet |
New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
Manufacturers: | AstraZeneca AB, Sodertalje, Sweden Catalent Pharma Solutions LLC, Kentucky, United States of America Wyeth Pharmaceutical Company, Guayama, Puerto Rico |
Product: | Nicorette Spearmint Gum |
Active Ingredient: | Nicotine polacrilex 10mg equivalent to nicotine 2mg |
Dosage Form: | Chewing gum |
New Zealand Sponsor: | Johnson & Johnson (New Zealand) Limited |
Manufacturer: | McNeil AB, Helsingborg, Sweden |
Product: | Nicorette Spearmint Gum |
Active Ingredient: | Nicotine polacrilex 20mg equivalent to nicotine 4mg |
Dosage Form: | Chewing gum |
New Zealand Sponsor: | Johnson & Johnson (New Zealand) Limited |
Manufacturer: | McNeil AB, Helsingborg, Sweden |
Product: | Vinorelbine Te Arai |
Active Ingredient: | Vinorelbine tartrate 27.7mg equivalent to vinorelbine 20mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Te Arai BioFarma Limited |
Manufacturer: | Lotus Pharmaceutical Co Limited, Nantou City, Taiwan |
Product: | Vinorelbine Te Arai |
Active Ingredient: | Vinorelbine tartrate 41.55mg equivalent to vinorelbine 30mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Te Arai BioFarma Limited |
Manufacturer: | Lotus Pharmaceutical Co Limited, Nantou City, Taiwan |
Product: | Vinorelbine Te Arai |
Active Ingredient: | Vinorelbine tartrate 110.8mg equivalent to vinorelbine 80mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Te Arai BioFarma Limited |
Manufacturer: | Lotus Pharmaceutical Co Limited, Nantou City, Taiwan |
Dated this 12th day of March 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).