Removab

RSS

catumaxomab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Removab has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 12/07/2017

Authorisation details

Product details
Name
Removab
Agency product number
EMEA/H/C/000972
Active substance
Catumaxomab
International non-proprietary name (INN) or common name
catumaxomab
Therapeutic area (MeSH)
  • Ascites
  • Cancer
Anatomical therapeutic chemical (ATC) code
L01XC09
Publication details
Marketing-authorisation holder
Neovii Biotech GmbH
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
20/04/2009
Contact address
Am Haag 6-7
82166 Graefelfing
Germany

Product information

02/06/2017 Removab - EMEA/H/C/000972 - IAIN/0020

Other EU languages available icon 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

Other antineoplastic agents

Therapeutic indication

Removab is indicated for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.

Assessment history

How useful was this page?

Add your rating
Average
5 ratings