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EMA Product

Pomalidomide Viatris

Product approved by European Medicines Agency (EU)

Basic Information

Pomalidomide Viatris

Regulatory Information

EMEA/H/C/006195

Authorised

February 16, 2024

December 14, 2023

1

March 12, 2024

Company Information

Ireland

Damastown Industrial Park Mulhuddart Dublin 15

VIATRIS PHARMA LIMITED

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Pomalidomide Viatris in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Viatris in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Overview Summary

Pomalidomide Viatris is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow). It is used in combination with bortezomib (another cancer medicine) and dexamethasone (an anti-inflammatory medicine) in adults who have received at least one treatment including lenalidomide (another cancer medicine). It is also used in combination with dexamethasone in adults who have received at least two prior therapies, including both lenalidomide and bortezomib, and whose disease has worsened. Pomalidomide Viatris is a ‘generic medicine’. This means that Pomalidomide Viatris contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Pomalidomide Viatris is Imnovid. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf). Pomalidomide Viatris contains the active substance pomalidomide

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