Notice Type
Departmental
Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

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:

Lenalide

Active Ingredient:

Lenalidomide 2.5mg

Dosage Form:

Capsule

New Zealand Sponsor:

Juno Pharmaceuticals NZ Limited

Manufacturer

Natco Pharma Limited, Telangana, India

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

  • Lenalide 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.
  • Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalide.

Note: This renewed consent is valid for two years from 8 September 2024.

   

Product:

Lenalide

Active Ingredient:

Lenalidomide 5mg

Dosage Form:

Capsule

New Zealand Sponsor:

Juno Pharmaceuticals NZ Limited

Manufacturer:

Natco Pharma Limited, Telangana, India


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

  • Lenalide 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.
  • Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalide.

Note: This renewed consent is valid for two years from 8 September 2024.

   

Product:

Lenalide

Active Ingredient:

Lenalidomide 7.5mg

Dosage Form:

Capsule

New Zealand Sponsor:

Juno Pharmaceuticals NZ Limited

Manufacturer:

Natco Pharma Limited, Telangana, India


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

  • Lenalide 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.
  • Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalide.

Note: This renewed consent is valid for two years from 8 September 2024.

   

Product:

Lenalide

Active Ingredient:

Lenalidomide 10mg

Dosage Form:

Capsule

New Zealand Sponsor:

Juno Pharmaceuticals NZ Limited

Manufacturer:

Natco Pharma Limited, Telangana, India

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

  • Lenalide 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.
  • Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalide.

Note: This renewed consent is valid for two years from 8 September 2024.

   

Product:

Lenalide

Active Ingredient:

Lenalidomide 15mg

Dosage Form:

Capsule

New Zealand Sponsor:

Juno Pharmaceuticals NZ Limited

Manufacturers:

Natco Pharma Limited, Telangana, India

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

  • Lenalide 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.
  • Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalide.

Note: This renewed consent is valid for two years from 8 September 2024.

   

Product:

Lenalide

Active Ingredient:

Lenalidomide 20mg

Dosage Form:

Capsule

New Zealand Sponsor:

Juno Pharmaceuticals NZ Limited

Manufacturers:

Natco Pharma Limited, Telangana, India

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

  • Lenalide 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.
  • Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalide.

Note: This renewed consent is valid for two years from 8 September 2024.

   

Product:

Lenalide

Active Ingredient:

Lenalidomide 25mg

Dosage Form:

Capsule

New Zealand Sponsor:

Juno Pharmaceuticals NZ Limited

Manufacturers:

Natco Pharma Limited, Telangana, India

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

  • Lenalide 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.
  • Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalide.

Note: This renewed consent is valid for two years from 8 September 2024.


Dated this 3rd day of September 2024.

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