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: Maxigesic Cold & Flu, Sinus & Pain Kit (Combination Product)
Component 1  
Active Ingredients: Ibuprofen 150mg
Paracetamol 500mg
Dosage Form: Film coated tablet
Component 2  
Active Ingredient: Xylometazoline hydrochloride 1mg/mL
Dosage Form: Nasal spray solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturers: Sigma Laboratories Private Limited, Mapusa, India
Qilu Pharmaceutical Co Limited, Jinan, China
Basic Pharma Manufacturing BV, Geleen, Netherlands
Yiling Pharmaceutical Limited (YPL), Shijiazhuang, China
   
Product: Univent
Active Ingredient: Ipratropium bromide monohydrate 20.87mcg/dose equivalent to Ipratropium bromide anhydrous 20mcg/dose
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Pithampur, India


Dated this 22nd day of August 2023.

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