Zaltrap
aflibercept
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Zaltrap. 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 Zaltrap.
For practical information about using Zaltrap, patients should read the package leaflet or contact their doctor or pharmacist.
Authorisation details
Product details | |
---|---|
Name |
Zaltrap
|
Agency product number |
EMEA/H/C/002532
|
Active substance |
aflibercept
|
International non-proprietary name (INN) or common name |
aflibercept
|
Therapeutic area (MeSH) |
Colorectal Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L01XX44
|
Publication details | |
---|---|
Marketing-authorisation holder |
Sanofi Winthrop Industrie
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
01/02/2013
|
Contact address |
82 Avenue Raspail |
Product information
15/12/2022 Zaltrap - EMEA/H/C/002532 - II/0067/G
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.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Treatment of metastatic colorectal cancer (MCRC).