Human medicines European public assessment report (EPAR): Pomalidomide Viatris, pomalidomide, Status: Opinion
Overview
On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pomalidomide Viatris, intended for multiple myeloma. The applicant for this medicinal product is Viatris Limited.
Pomalidomide Viatris will be available as 1 mg, 2 mg, 3 mg and 4 mg hard capsules. The active substance of Pomalidomide Viatris is pomalidomide, an immunomodulator (ATC code: L04AX06) that works in a number of different ways, including through cytokine modulation, induction of T-cell proliferation, anti-proliferation of multiple myeloma cells and inhibition of angiogenesis.
Pomalidomide Viatris is a generic of Imnovid, which has been authorised in the EU since 05 August 2013. Studies have demonstrated the satisfactory quality of Pomalidomide Viatris and its bioequivalence to the reference product Imnovid. A question and answer document on generic medicines can be found here.
The full indication is:
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.
Treatment with Pomalidomide Viatris should be carried out under the supervision of physicians experienced in the treatment of multiple myeloma.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
CHMP summary of positive opinion for Pomalidomide Viatris
First published: Reference Number: EMA/CHMP/554066/2023
Product details
- Name of medicine
Pomalidomide Viatris
- Active substance
Pomalidomide
- International proprietary name (INN) or common name
pomalidomide
- Therapeutic area (MeSH)
Multiple Myeloma
- Anatomical therapeutic chemical (ATC) code
L04AX06
- EMA product number
EMEA/H/C/006195
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
- Marketing authorisation applicant
Viatris Limited
- Opinion adopted
14/12/2023
- Opinion status
Positive
This page was last updated on
Share this page
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
