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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Removab has been withdrawn at the request of the marketing authorisation holder.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
19/04/2009
Contact address
Am Haag 6-7
82166 Graefelfing
Germany

Product information

01/06/2017 Removab - EMEA/H/C/000972 - IAIN/0020

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

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

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