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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: Pomalidomide Sandoz
Active Ingredient: Pomalidomide 1mg
Dosage Form: Capsule
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: Synthon Hispania SL, Barcelona, Spain

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

  1. Pomalidomide Sandoz may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine.
  2. Sandoz New Zealand Limited will manage a pregnancy prevention programme relating to the distribution and use of Pomalidomide Sandoz.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Pomalidomide Sandoz
Active Ingredient: Pomalidomide 2mg
Dosage Form: Capsule
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: Synthon Hispania SL, Barcelona, Spain

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

  1. Pomalidomide Sandoz may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine.
  2. Sandoz New Zealand Limited will manage a pregnancy prevention programme relating to the distribution and use of Pomalidomide Sandoz.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Pomalidomide Sandoz
Active Ingredient: Pomalidomide 3mg
Dosage Form: Capsule
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: Synthon Hispania SL, Barcelona, Spain

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

  1. Pomalidomide Sandoz may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine.
  2. Sandoz New Zealand Limited will manage a pregnancy prevention programme relating to the distribution and use of Pomalidomide Sandoz.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Pomalidomide Sandoz
Active Ingredient: Pomalidomide 4mg
Dosage Form: Capsule
New Zealand Sponsor: Sandoz New Zealand Limited
Manufacturer: Synthon Hispania SL, Barcelona, Spain

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

  1. Pomalidomide Sandoz may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine.
  2. Sandoz New Zealand Limited will manage a pregnancy prevention programme relating to the distribution and use of Pomalidomide Sandoz.
Note: This consent is valid for two years from the date of publication of this notice.


Dated this 8th day of December 2023.

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

Publication Date
14 Dec 2023

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2023-go5784
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