This is a summary of the European public assessment report (EPAR) for Caprelsa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Caprelsa.
For practical information about using Caprelsa, patients should read the package leaflet or contact their doctor or pharmacist.
Caprelsa : EPAR - Summary for the public (PDF/81.48 KB)
First published: 02/03/2012
Last updated: 09/02/2017
Caprelsa : EPAR - Risk-management-plan summary (PDF/78.85 KB)
First published: 05/11/2019
Last updated: 07/12/2020
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This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
Genzyme Europe BV
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30/05/2022 Caprelsa - EMEA/H/C/002315 - II/0052
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Antineoplastic and immunomodulating agents
Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
Caprelsa is indicated in adults, children and adolescents aged 5 years and older.
For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.