Removab

catumaxomab

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The marketing authorisation for Removab has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Removab : EPAR - Summary for the public BG = bălgarski 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public ES = español 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public CS = čeština 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public DA = dansk 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public DE = Deutsch 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public ET = eesti keel 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public EL = elliniká 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public EN = English 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public FR = français 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public IT = italiano 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public LV = latviešu valoda 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public LT = lietuvių kalba 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public HU = magyar 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public MT = Malti 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public NL = Nederlands 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public PL = polski 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public PT = português 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public RO = română 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public SK = slovenčina 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public SL = slovenščina 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public FI = suomi 2009-05-12 2017-07-12
Removab : EPAR - Summary for the public SV = svenska 2009-05-12 2017-07-12

This EPAR was last updated on 12/07/2017 .

Authorisation details

Product details

Product details for Removab
NameRemovab
Agency product numberEMEA/H/C/000972
Active substance

catumaxomab

International non-proprietary name (INN) or common name

catumaxomab

Therapeutic area AscitesCancer
Anatomical therapeutic chemical (ATC) code L01XC09

Publication details

Publication details for Removab
Marketing-authorisation holder

Neovii Biotech GmbH

Revision5
Date of issue of marketing authorisation valid throughout the European Union20/04/2009

Contact address:

Neovii Biotech GmbH
Am Haag 6-7
82166 Graefelfing
Germany

Product information

Product information

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

Name Language First published Last updated
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - Product Information SV = svenska 2009-05-06 2017-07-12

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.


Name Language First published Last updated
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12
Removab : EPAR - All Authorised presentations SV = svenska 2009-05-06 2017-07-12

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Removab: EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-05-06 2017-07-12

Initial marketing-authorisation documents

Name Language First published Last updated
Removab : EPAR - Public assessment report SV = svenska 2009-05-12 2017-07-12
Committee for medicinal products for human use, summary of positive opinion for Removab SV = svenska 2009-02-18 2017-07-12

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Removab