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 26/07/2018

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
L01XE05
Orphan

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 Pharma AG
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
19/07/2006
Contact address
13342 Berlin
Germany

Product information

25/06/2018 Nexavar - EMEA/H/C/000690 - IB/0046

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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