Notice Type
Departmental
Notice Title

Renewal of Provisional Consent to the Distribution of a New Medicine

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 medicine set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Benztropine Omega
Benzatropine mesilate 1mg/mL
Solution for injection
A. Menarini New Zealand Pty Limited
Omega Laboratories, Montreal, Canada

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

  • Provisional consent is to be granted for 2 years to address an urgent shortage in the market.
  • Provisional consent is given subject to the following restriction: The medicine may only be marketed or distributed when no other benztropine mesylate solution for injection medicine with consent to distribute is available in the New Zealand market and to meet sole tender obligations.
  • Provisional consent can only be renewed while assessment of a section 20 new medicine application is in progress. The new medicine application should be accompanied by a full data set in compliance with Medsafe‚Äôs stated requirements.

Also note: This renewed consent is valid for two years from 22 June 2019.

Dated this 14th day of June 2019.

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