Notice Title

Provisional Consent to the Distribution of a New Medicine

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 medicine set out in the Schedule hereto:

Schedule

Product: Avallon Paracetamol For Children 5 to 12 Years
Active Ingredient: Paracetamol 48mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Gracure Pharmaceuticals Limited, Bhiwadi, India

Note: This consent is given subject to the following condition:

  • The medicine may only be marketed or distributed to meet an emergency PHARMAC tender and may not be sold in other circumstances.

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

Dated this 23rd day of September 2022.

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