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: Cosentyx (75mg/0.5mL) (Pre-filled syringe)
Active Ingredient: Secukinumab 150mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
   
Product: Cosentyx (300mg/2mL) (Pre-filled syringe)
Active Ingredient: Secukinumab 150mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
   
Product: Cosentyx (300mg/2mL) (Pre-filled pen)
Active Ingredient: Secukinumab 150mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
   
Product: Diacomit
Active Ingredient: Stiripentol 250mg
Dosage Form: Capsule
New Zealand Sponsor: Chiesi New Zealand Limited t/a Emerge Health
Manufacturer: Biocodex SAS, Beauvais, France
   
Product: Diacomit
Active Ingredient: Stiripentol 250mg
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Chiesi New Zealand Limited t/a Emerge Health
Manufacturer: Biocodex SAS, Beauvais, France
   
Product: Diacomit
Active Ingredient: Stiripentol 500mg
Dosage Form: Capsule
New Zealand Sponsor: Chiesi New Zealand Limited t/a Emerge Health
Manufacturer: Biocodex SAS, Beauvais, France
   
Product: Diacomit
Active Ingredient: Stiripentol 500mg
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Chiesi New Zealand Limited t/a Emerge Health
Manufacturer: Biocodex SAS, Beauvais, France
   
Product: Difflam Plus Sore Throat Spray Anaesthetic + Antibacterial + Anti-inflammatory Triple Action
Active Ingredients: Benzydamine hydrochloride 3mg/mL
Dichlorobenzyl alcohol 2.6mg/mL
Lidocaine hydrochloride monohydrate 4.3mg/mL
Dosage Form: Oral spray
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Ensign Laboratories Pty Limited, Melbourne, Australia
   
Product: Irbesartan (Medicianz)
Active Ingredient: Irbesartan 75mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medicianz Healthcare Limited
Manufacturer: Micro Labs Limited, Verna, India
   
Product: Irbesartan (Medsurge)
Active Ingredient: Irbesartan 75mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medicianz Healthcare Limited
Manufacturer: Micro Labs Limited, Verna, India
   
Product: Irbesartan (Medicianz)
Active Ingredient: Irbesartan 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medicianz Healthcare Limited
Manufacturer: Micro Labs Limited, Verna, India
   
Product: Irbesartan (Medsurge)
Active Ingredient: Irbesartan 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medicianz Healthcare Limited
Manufacturer: Micro Labs Limited, Verna, India
   
Product: Irbesartan (Medicianz)
Active Ingredient: Irbesartan 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medicianz Healthcare Limited
Manufacturer: Micro Labs Limited, Verna, India
   
Product: Irbesartan (Medsurge)
Active Ingredient: Irbesartan 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medicianz Healthcare Limited
Manufacturer: Micro Labs Limited, Verna, India


Dated this 29th day of March 2023.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).