Nexavar

RSS

sorafenib

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 10/05/2022

Authorisation details

Product details
Name
Nexavar
Agency product number
EMEA/H/C/000690
Active substance
sorafenib
International non-proprietary name (INN) or common name
sorafenib
Therapeutic area (MeSH)
  • Carcinoma, Hepatocellular
  • Carcinoma, Renal Cell
Anatomical therapeutic chemical (ATC) code
L01EX02
OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Bayer AG
Revision
30
Date of issue of marketing authorisation valid throughout the European Union
19/07/2006
Contact address

Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Product information

09/05/2022 Nexavar - EMEA/H/C/000690 - IAIN/0056

Product information documents contain:

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.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Hepatocellular carcinoma

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.

Assessment history

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