Questions & Answers
On 28 January2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Revlimid. The marketing authorisation holder for this medicinal product is Celgene Europe Limited.
The CHMP adopted a new indication as follows:
"Revlimid is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1)."
For information, the full indications for Revlimid will be as follows1:
Revlimid is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant (see section 4.2).
Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Revlimid is indicated for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
Mantle cell lymphoma
Revlimid is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1)."
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1New text in bold
|Name||Language||First published||Last updated|
|CHMP post-authorisation summary of positive opinion for Revlimid||(English only)||29/01/2016|
|INN or common name|
|Therapeutic area||Multiple Myeloma|
|Date opinion adopted||28/01/2016|
Celgene Europe Limited
|Application type||Post authorisation|