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Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

Publication Date
24 Apr 2024

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2024-go1849
Title
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File Type and Size
PDF (35 KB)

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
Active Ingredient: Clomipramine hydrochloride 10mg
Dosage Form: Capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Teva Pharmaceutical Works Private Limited Company, Debrecen, Hungary

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 PHARMAC supply obligations.
Also Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Clomipramine
Active Ingredient: Clomipramine hydrochloride 25mg
Dosage Form: Capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Teva Pharmaceutical Works Private Limited Company, Debrecen, Hungary

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 PHARMAC supply obligations.
Also Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Oramorph
Active Ingredient: Morphine sulfate pentahydrate 2mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Clinect NZ Pty Limited
Manufacturer: Istituto de Angeli SrL, Florence, Italy

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

  • The medicine may only be marketed or distributed when no other morphine oral solution medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations.
Also Note: This consent is valid for two years from the date of publication of this notice.


Dated this 19th day of April 2024.

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