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Notice Type
Departmental
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:
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:

  • 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.

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

Dated this 19th day of June 2017.

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