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:

Lenalidomide Sandoz

Active Ingredient:

Lenalidomide 5mg

Dosage Form:

Capsule

New Zealand Sponsor:

Sandoz New Zealand Limited

Manufacturer:

Synthon Chile Ltda., Santiago, Chile

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

  1. Lenalidomide 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 Lenalidomide Sandoz.

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

   

Product:

Lenalidomide Sandoz

Active Ingredient:

Lenalidomide 10mg

Dosage Form:

Capsule

New Zealand Sponsor:

Sandoz New Zealand Limited

Manufacturer:

Synthon Chile Ltda., Santiago, Chile

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

  1. Lenalidomide 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 Lenalidomide Sandoz.

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

   

Product:

Lenalidomide Sandoz

Active Ingredient:

Lenalidomide 15mg

Dosage Form:

Capsule

New Zealand Sponsor:

Sandoz New Zealand Limited

Manufacturer:

Synthon Chile Ltda., Santiago, Chile

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

  1. Lenalidomide 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 Lenalidomide Sandoz.

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

   

Product:

Lenalidomide Sandoz

Active Ingredient:

Lenalidomide 25mg

Dosage Form:

Capsule

New Zealand Sponsor:

Sandoz New Zealand Limited

Manufacturer:

Synthon Chile Ltda., Santiago, Chile

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

1. Lenalidomide 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 Lenalidomide Sandoz.

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

   

Product:

Lenalidomide Viatris

Active Ingredient:

Lenalidomide 2.5mg

Dosage Form:

Capsule

New Zealand Sponsor:

Viatris Limited

Manufacturer:

Mylan Laboratories Limited, Pithampur, India

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

  1. Lenalidomide Viatris 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.

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

   

Product:

Lenalidomide Viatris

Active Ingredient:

Lenalidomide 5mg

Dosage Form:

Capsule

New Zealand Sponsor:

Viatris Limited

Manufacturer:

Mylan Laboratories Limited, Pithampur, India

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

  1. Lenalidomide Viatris 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.

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

   

Product:

Lenalidomide Viatris

Active Ingredient:

Lenalidomide 7.5mg

Dosage Form:

Capsule

New Zealand Sponsor:

Viatris Limited

Manufacturer:

Mylan Laboratories Limited, Pithampur, India

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

  1. Lenalidomide Viatris 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.

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

   

Product:

Lenalidomide Viatris

Active Ingredient:

Lenalidomide 10mg

Dosage Form:

Capsule

New Zealand Sponsor:

Viatris Limited

Manufacturer:

Mylan Laboratories Limited, Pithampur, India

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

  1. Lenalidomide Viatris 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.

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

   

Product:

Lenalidomide Viatris

Active Ingredient:

Lenalidomide 15mg

Dosage Form:

Capsule

New Zealand Sponsor:

Viatris Limited

Manufacturer:

Mylan Laboratories Limited, Pithampur, India

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

  1. Lenalidomide Viatris 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.

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

   

Product:

Lenalidomide Viatris

Active Ingredient:

Lenalidomide 20mg

Dosage Form:

Capsule

New Zealand Sponsor:

Viatris Limited

Manufacturer:

Mylan Laboratories Limited, Pithampur, India

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

  1. Lenalidomide Viatris 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.

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

   

Product:

Lenalidomide Viatris

Active Ingredient:

Lenalidomide 25mg

Dosage Form:

Capsule

New Zealand Sponsor:

Viatris Limited

Manufacturer:

Mylan Laboratories Limited, Pithampur, India

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

  1. Lenalidomide Viatris 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.

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


Dated this 11th day of September 2023.

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