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: Clomipramine-Teva
Active Ingredient: Clomipramine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Teva Operations Poland Sp., Krakow, Poland

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

This consent is given subject to the following condition:

  • The medicine may only be marketed or distributed when no other clomipramine medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Product: Clomipramine-Teva
Active Ingredient: Clomipramine hydrochloride 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Teva Operations Poland Sp., Krakow, Poland

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

This consent is given subject to the following condition:

  • The medicine may only be marketed or distributed when no other clomipramine medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.


Dated this 9th day of September 2021.

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