Removab

Withdrawn

This medicine's authorisation has been withdrawn

catumaxomab

Overview

The marketing authorisation for Removab has been withdrawn at the request of the marketing authorisation holder.

Removab : EPAR - Summary for the public

Product information

Removab : EPAR - Product Information

Latest procedure affecting product information: IAIN/0020

02/06/2017

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).

Removab : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Removab
• Active substance:
  Catumaxomab
• International non-proprietary name (INN) or common name:
  catumaxomab
• Therapeutic area (MeSH):
  • Ascites
  • Cancer
• Anatomical therapeutic chemical (ATC) code:
  L01XC09

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000972
• Marketing authorisation holder:
  Neovii Biotech GmbH

  Am Haag 6-7; 82166 Graefelfing; Germany

• Marketing authorisation issued:
  20/04/2009
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

Removab: EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Removab : EPAR - Public assessment report

CHMP summary of positive opinion for Removab

Reference Number: EMEA/CHMP/100097/2009