Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:
Schedule
Product: Pinorax
Active Ingredients: Dantron 5mg/mL
Poloxamer 188 40mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Tipperary, Ireland
Note: This consent is given subject to the following condition:
- Pinorax may only be used for the prevention or treatment of constipation in the terminally ill.
Note: This renewed consent is valid for two years from 22 April 2014.
Product: Pinorax
Active Ingredients: Dantron 15mg/mL
Poloxamer 188 200mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Tipperary, Ireland
Note: This consent is given subject to the following condition:
- Pinorax may only be used for the prevention or treatment of constipation in the terminally ill.
Note: This renewed consent is valid for two years from 22 April 2014.
Dated this 3rd day of April 2014.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).