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Notice Type
Departmental
Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Publication Date
7 Sep 2023

Tags

Medicines Act Renewal of provisional consent to the distribution of medicines Health

Notice Number

2023-go4168
Title
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File Type and Size
PDF (35 KB)

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 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


Note: 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.
Note: This renewed consent is valid for two years from 10 September 2023.
   
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


Note: 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.
Note: This renewed consent is valid for two years from 10 September 2023.


Dated this 4th day of September 2023.

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