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: Cyclogest
Active Ingredient: Progesterone 400mg
Dosage Form: Pessary
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Accord UK Limited, Barnstaple, United Kingdom
   
Product: Fingolimod Devatis
Active Ingredient: Fingolimod hydrochloride 0.56mg equivalent to fingolimod 0.50mg
Dosage Form: Capsule
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey
   
Product: Fulvestrant Sandoz
Active Ingredient: Fulvestrant 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: FAREVA Unterach GmbH, Unterach am Attersee, Austria
   
Product: Ibuprofen (GenericPharm) (General sale)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Shandong Xinhua Pharmaceutical Co Limited, Zibo, China
   
Product: Ibuprofen (GenericPharm) (Pharmacy only)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Shandong Xinhua Pharmaceutical Co Limited, Zibo, China
   
Product: Ibuprofen (MedPharm) (General sale)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Shandong Xinhua Pharmaceutical Co Limited, Zibo, China
   
Product: Ibuprofen (MedPharm) (Pharmacy only)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Shandong Xinhua Pharmaceutical Co Limited, Zibo, China
   
Product: Ibuprofen (MedPharm) (Prescription)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Shandong Xinhua Pharmaceutical Co Limited, Zibo, China
   
Product: Ibuprofen (MedTech) (General sale)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Shandong Xinhua Pharmaceutical Co Limited, Zibo, China
   
Product: Ibuprofen (MedTech) (Pharmacy only)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ethos Consulting Group
Manufacturer: Shandong Xinhua Pharmaceutical Co Limited, Zibo, China
   
Product: Levonorgestrel-1
Active Ingredient: Levonorgestrel 1.5mg
Dosage Form: Tablet
New Zealand Sponsor: Max Health Limited
Manufacturer: Lupin Limited, Pithampur, India
   
Product: Nurofen Zavance Mini Liquid Capsules (General sale)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Patheon Softgels B.V., Tilburg, Netherlands
   
Product: Nurofen Zavance Mini Liquid Capsules (Pharmacy only)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Patheon Softgels B.V., Tilburg, Netherlands


Dated this 4th day of March 2024.

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