Table of contents
This is a summary of the European public assessment report (EPAR) for Nexavar. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nexavar.
Nexavar : EPAR - Summary for the public (PDF/82.51 KB)
First published: 18/05/2009
Last updated: 18/06/2014
Nexavar : EPAR - Risk Management Plan (PDF/2.92 MB)
First published: 06/12/2022
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|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
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This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
|Date of issue of marketing authorisation valid throughout the European Union||
19/10/2022 Nexavar - EMEA/H/C/000690 - IA/0057
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
Nexavar is indicated for the treatment of hepatocellular carcinoma.
Renal cell carcinoma
Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Differentiated thyroid carcinoma
Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.