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).