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: | Abiraterone Sandoz |
Active Ingredient: | Abiraterone acetate 250mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Remedica Limited, Limassol, Cyprus |
Product: | Abiraterone Sandoz |
Active Ingredient: | Abiraterone acetate 500mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Remedica Limited, Limassol, Cyprus |
Product: | Abiraterone Sandoz |
Active Ingredient: | Abiraterone acetate 1000mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Remedica Limited, Limassol, Cyprus |
Product: | Alburex 20 NZ (10g/50mL) |
Active Ingredient: | Albumin 200mg/mL |
Dosage Form: | Solution for infusion |
New Zealand Sponsor: | CSL Behring (NZ) Limited |
Manufacturer: | CSL Behring (Australia) Pty Limited, Melbourne, Australia |
Product: | Alburex 20 NZ (20g/100mL) |
Active Ingredient: | Albumin 200mg/mL |
Dosage Form: | Solution for infusion |
New Zealand Sponsor: | CSL Behring (NZ) Limited |
Manufacturer: | CSL Behring (Australia) Pty Limited, Melbourne, Australia |
Product: | Azacitidine Sandoz |
Active Ingredient: | Azacitidine 100mg |
Dosage Form: | Powder for injection |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | MSN Laboratories Private Limited, Nandigama, India |
Product: | Breztri Aerosphere |
Active Ingredients: | Budesonide 160mcg Formoterol fumarate dihydrate 5mcg Glycopyrronium bromide 9mcg equivalent to glycopyrronium 7.2mcg |
Dosage Form: | Aerosol inhaler, metered dose |
New Zealand Sponsor: | AstraZeneca Limited |
Manufacturer: | AstraZeneca Dunkerque Production SCS, Dunkerque, France |
Product: | Daptomycin |
Active Ingredient: | Daptomycin 350mg |
Dosage Form: | Powder for infusion |
New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
Manufacturer: | Hikma Italia S.P.A, Pavia, Italy |
Product: | Daptomycin |
Active Ingredient: | Daptomycin 500mg |
Dosage Form: | Powder for infusion |
New Zealand Sponsor: | Juno Pharmaceuticals NZ Limited |
Manufacturer: | Hikma Italia S.P.A, Pavia, Italy |
Product: | Remsima SC (Pre-filled pen) |
Active Ingredient: | Infliximab 120mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
Product: | Remsima SC (Pre-filled syringe) |
Active Ingredient: | Infliximab 120mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany |
Product: | Ryzodeg 70/30 FlexTouch |
Active Ingredients: | Insulin aspart 30U/mL Insulin degludec 70U/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
Manufacturers: | Novo Nordisk A/S, Copenhagen, Denmark Novo Nordisk Production SAS, Chartres, France |
Product: | Ryzodeg 70/30 Penfill |
Active Ingredients: | Insulin aspart 30U/mL Insulin degludec 70U/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | Novo Nordisk Pharmaceuticals Limited |
Manufacturers: | Novo Nordisk A/S, Copenhagen, Denmark Novo Nordisk Production SAS, Chartres, France |
Product: | Skyrizi |
Active Ingredient: | Risankizumab 150mg/mL |
Dosage Form: | Solution for injection |
New Zealand Sponsor: | AbbVie Limited |
Manufacturer: | Patheon Italia S.p.A, Milan, Italy |
Product: | Skyrizi |
Active Ingredient: | Risankizumab 60mg/mL |
Dosage Form: | Concentrate for infusion |
New Zealand Sponsor: | AbbVie Limited |
Manufacturer: | Patheon Italia S.p.A, Milan, Italy |
Product: | Sunitinib |
Active Ingredient: | Sunitinib malate 16.7mg equivalent to sunitinib 12.5mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | REX Medical Limited |
Manufacturer: | Atlas Pharm S.A., Casablanca, Morocco |
Product: | Sunitinib |
Active Ingredient: | Sunitinib malate 33.4mg equivalent to sunitinib 25mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | REX Medical Limited |
Manufacturer: | Atlas Pharm S.A., Casablanca, Morocco |
Product: | Sunitinib |
Active Ingredient: | Sunitinib malate 66.8mg equivalent to sunitinib 50mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | REX Medical Limited |
Manufacturer: | Atlas Pharm S.A., Casablanca, Morocco |
Product: | Telfast |
Active Ingredient: | Fexofenadine hydrochloride 180mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
Manufacturer: | Sanofi Winthrop Industrie, Tours, France |
Product: | Vizo-PF Dorzolatim |
Active Ingredients: | Dorzolamide hydrochloride 22.26mg/mL equivalent to dorzolamide 20mg/mL Timolol maleate 6.83mg/mL equivalent to timolol 5mg/mL |
Dosage Form: | Eye drops, solution |
New Zealand Sponsor: | AFT Pharmaceuticals Limited |
Manufacturer: | Excelvision, Annonay, France |
Dated this 30th day of May 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).