Nexavar
sorafenib
Table of contents
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.
Authorisation details
Product details | |
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Name |
Nexavar
|
Agency product number |
EMEA/H/C/000690
|
Active substance |
sorafenib
|
International non-proprietary name (INN) or common name |
sorafenib
|
Therapeutic area (MeSH) |
|
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 | |
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Marketing-authorisation holder |
Bayer AG
|
Revision |
28
|
Date of issue of marketing authorisation valid throughout the European Union |
19/07/2006
|
Contact address |
Product information
04/10/2019 Nexavar - EMEA/H/C/000690 - IAIN/0051
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
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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.