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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: 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).