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: Lenalidomide Devatis
Active Ingredient: Lenalidomide 2.5mg
Dosage Form: Capsule
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey

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

  • Lenalidomide Devatis 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.
  • Devatis Limited must manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Devatis.

Note: This renewed consent is valid for two years from 22 December 2024.

 
Product: Lenalidomide Devatis
Active Ingredient: Lenalidomide 5mg
Dosage Form: Capsule
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey

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

  • Lenalidomide Devatis 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.
  • Devatis Limited must manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Devatis.

Note: This renewed consent is valid for two years from 22 December 2024.

 
Product: Lenalidomide Devatis
Active Ingredient: Lenalidomide 7.5mg
Dosage Form: Capsule
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey

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

  • Lenalidomide Devatis 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.
  • Devatis Limited must manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Devatis.

Note: This renewed consent is valid for two years from 22 December 2024.

   
Product: Lenalidomide Devatis
Active Ingredient: Lenalidomide 10mg
Dosage Form: Capsule
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey

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

  • Lenalidomide Devatis 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.
  • Devatis Limited must manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Devatis.

Note: This renewed consent is valid for two years from 22 December 2024.

 
Product: Lenalidomide Devatis
Active Ingredient: Lenalidomide 15mg
Dosage Form: Capsule
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey

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

  • Lenalidomide Devatis 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.
  • Devatis Limited must manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Devatis. 

Note: This renewed consent is valid for two years from 22 December 2024.

 
Product: Lenalidomide Devatis
Active Ingredient: Lenalidomide 20mg
Dosage Form: Capsule
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey

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

  • Lenalidomide Devatis 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.
  • Devatis Limited must manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Devatis.

Note: This renewed consent is valid for two years from 22 December 2024.

 
Product: Lenalidomide Devatis
Active Ingredient: Lenalidomide 25mg
Dosage Form: Capsule
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey

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

  • Lenalidomide Devatis 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.
  • Devatis Limited must manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Devatis.

Note: This renewed consent is valid for two years from 22 December 2024.


Dated this 16th day of December 2024.

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