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: Azonaire Hayfever & Allergy Prevention & Relief
Active Ingredient: Mometasone furoate monohydrate 0.5mg/g
Dosage Form: Nasal spray suspension
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Lek Pharmaceuticals d.d., Ljubljana, Slovenia
   
Product: Ibuprofen (Multichem)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
   
Product: Picoprep Orange
Active Ingredients: Citric acid 12.2g
Magnesium carbonate monohydrate 7.4g
Sodium picosulfate 10.3mg
Dosage Form: Powder for oral solution
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia
   
Product: Symbicort Rapihaler 100/3
Active Ingredients: Budesonide 80mcg
Formoterol fumarate 2.25mcg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca Dunkerque Production SCS, Dunkerque, France
   
Product: Valproate-AFT
Active Ingredient: Sodium valproate 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Labiana Pharmaceuticals S.L.U., Barcelona, Spain


Dated this 13th day of December 2021.

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