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: 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).