Removab
Withdrawn
This medicine's authorisation has been withdrawn
catumaxomab
Medicine
Human
Withdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 2 June 2017, the European Commission withdrew the marketing authorisation for Removab (catumaxomab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Neovii Biotech GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Removab was granted marketing authorisation in the EU on 20 April 2009 for treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2013. The product had not been marketed in the EU since 2014.
The European Public Assessment Report (EPAR) for Removab is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
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).
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 agentsTherapeutic 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.
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