Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Pinorax
Dantron 5mg/mL
Poloxamer 188 40mg/mL
Oral suspension
AFT Pharmaceuticals Limited
Pinewood Laboratories Limited, Clonmel, 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.

Also note: This renewed consent is valid for two years from the date of publication of this notice.

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Pinorax
Dantron 15mg/mL
Poloxamer 188 200mg/mL
Oral suspension
AFT Pharmaceuticals Limited
Pinewood Laboratories Limited, Clonmel, 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.

Also note: This renewed consent is valid for two years from the date of publication of this notice.

Dated this 19th day of May 2016.

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