Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Removab   
Auth. number : EU/1/09/512
INN : Catumaxomab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC09 - Catumaxomab
(See WHO ATC Index)
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
Marketing Authorisation Holder: Neovii Biotech GmbH
Am Haag 6-7, 82166 Graefelfing, Deutschland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
22/04/2009 Centralised - Authorisation EMEA/H/C/972 (2009)3071 of 20/04/2009
14/12/2009 Centralised - Variation EMEA/H/C/972/IB/1
Updated with Decision(2010)1788 of 15/03/2010
19/02/2010 Centralised - Variation EMEA/H/C/972/IA/2/G
17/03/2010 Centralised - Variation (2010)1788 of 15/03/2010
06/09/2010 Centralised - Variation EMEA/H/C/972/IA/5
13/10/2010 Centralised - Variation EMEA/H/C/972/IA/6
22/11/2010 Centralised - Variation EMEA/H/C/972/IB/7
Updated with Decision(2011)5059 of 07/07/2011
11/07/2011 Centralised - Variation (2011)5059 of 07/07/2011
07/09/2011 Centralised - Variation EMEA/H/C/972/II/9, 10 (2011)6374 of 05/09/2011
13/12/2012 Centralised - Variation EMEA/H/C/972/II/16/G
Updated with Decision(2013)9724 of 18/12/2013
19/12/2013 Centralised - Variation EMEA/H/C/972/IA/20/G
20/12/2013 Centralised - Renewal EMEA/H/C/972/R/19 (2013)9724 of 18/12/2013