Removab

RSS
Withdrawn

This medicine's authorisation has been withdrawn

catumaxomab
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Removab has been withdrawn at the request of the marketing authorisation holder.

Removab : EPAR - Summary for the public

English (EN) (487.7 KB - PDF)

First published: Last updated:
View

български (BG) (619.17 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

español (ES) (487.88 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

čeština (CS) (601.56 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

dansk (DA) (487.88 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

Deutsch (DE) (489.31 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

eesti keel (ET) (499.17 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

ελληνικά (EL) (632.41 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

français (FR) (488.88 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

italiano (IT) (488.25 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

latviešu valoda (LV) (602.02 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

lietuvių kalba (LT) (570.59 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

magyar (HU) (593.2 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

Malti (MT) (617.05 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

Nederlands (NL) (510.15 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

polski (PL) (606.08 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

português (PT) (487.9 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

română (RO) (569.84 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

slovenčina (SK) (598.37 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

slovenščina (SL) (586.62 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

Suomi (FI) (487.89 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

svenska (SV) (489.48 KB - PDF)

First published: 12/05/2009Last updated: 12/07/2017
View

Product information

Removab : EPAR - Product Information

English (EN) (1.25 MB - PDF)

First published: Last updated:
View

български (BG) (2.42 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

español (ES) (1.42 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

čeština (CS) (2.01 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

dansk (DA) (1.25 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

Deutsch (DE) (1.36 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

eesti keel (ET) (1.26 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

ελληνικά (EL) (2.49 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

français (FR) (1.39 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

hrvatski (HR) (1.35 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

íslenska (IS) (1.27 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

italiano (IT) (1.29 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

latviešu valoda (LV) (2.06 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

lietuvių kalba (LT) (1.38 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

magyar (HU) (2.14 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

Malti (MT) (2.08 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

Nederlands (NL) (1.29 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

norsk (NO) (1.76 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

polski (PL) (2.21 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

português (PT) (1.28 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

română (RO) (1.54 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

slovenčina (SK) (2.05 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

slovenščina (SL) (2 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

Suomi (FI) (1.29 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

svenska (SV) (1.27 MB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View
Latest procedure affecting product information: IAIN/0020
02/06/2017
icon globe

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

English (EN) (456.74 KB - PDF)

First published: Last updated:
View

български (BG) (520.46 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

español (ES) (456.72 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

čeština (CS) (509.49 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

dansk (DA) (456.81 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

Deutsch (DE) (456.81 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

eesti keel (ET) (457.58 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

ελληνικά (EL) (514.57 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

français (FR) (457.33 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

italiano (IT) (456.77 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

latviešu valoda (LV) (513.5 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

lietuvių kalba (LT) (496.02 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

magyar (HU) (504.19 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

Malti (MT) (511.71 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

Nederlands (NL) (456.72 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

polski (PL) (506.7 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

português (PT) (456.89 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

română (RO) (500.36 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

slovenčina (SK) (507.38 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

slovenščina (SL) (480.94 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

Suomi (FI) (456.66 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

svenska (SV) (457.12 KB - PDF)

First published: 06/05/2009Last updated: 12/07/2017
View

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

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

English (EN) (546.04 KB - PDF)

First published: Last updated:
View

Removab : EPAR - Public assessment report

English (EN) (1.18 MB - PDF)

First published: Last updated:
View

CHMP summary of positive opinion for Removab

Reference Number: EMEA/CHMP/100097/2009

English (EN) (477.25 KB - PDF)

First published: Last updated:
View

More information on Removab

Public statement on Removab: Withdrawal of the marketing authorisation in the European Union

English (EN) (58.72 KB - PDF)

First published: Last updated:
View
This page was last updated on

Share this page

Back to top