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 are set out in the Schedule hereto:

Schedule

*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: 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.
Note: This renewed consent is valid for two years from 14 September 2025.

*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: 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.
Note: This renewed consent is valid for two years from 14 September 2025.

*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: 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.
Note: This renewed consent is valid for two years from 14 September 2025.

*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: 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.
Note: This renewed consent is valid for two years from 14 September 2025.

*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: 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.
Note: This renewed consent is valid for two years from 14 September 2025.

*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: 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.
Note: This renewed consent is valid for two years from 14 September 2025.

*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: 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. Viatris Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Viatris.
Note: This renewed consent is valid for two years from 14 September 2025.

Dated this 9th day of September 2025.

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

Renewal of Provisional Consent to the Distribution of Medicines

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