Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Beromun   
Auth. number : EU/1/99/097
Active substance : Tasonermin (Tumor Necrosis Factor alfa-1a)
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L03 - Immunomodulating agents
Pharmacological subgroup: L03A - Immunostimulating agents
Chemical subgroup: L03AX - Other immunostimulating agents
Chemical substance: L03AX11 - Tasonermin
(See WHO ATC Index)
Indication: As an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated limb perfusion (ILP).
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, 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 is 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
15/04/1999 Centralised - Authorisation EMEA/H/C/206 (1999)933 of 13/04/1999
05/08/1999 Centralised - Variation EMEA/H/C/206/I/1 (1999)2546 of 29/07/1999
05/08/1999 Centralised - Variation EMEA/H/C/206/I/2 (1999)2546 of 29/07/1999
05/08/1999 Centralised - Notification EMEA/H/C/206/N/3 (1999)2546 of 29/07/1999
16/11/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/206/I/4
28/01/2002 Centralised - Variation EMEA/H/C/206/II/5 (2002)408 of 28/01/2002
19/12/2002 Centralised - Notification EMEA/H/C/206/N/7 (2002)5408 of 16/12/2002
28/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/206/II/6
23/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/206/II/9
29/01/2004 Centralised - Variation EMEA/H/C/206/II/8 (2004)232 of 27/01/2004
21/06/2004 Centralised - Renewal EMEA/H/C/206/R/10 (2004)2241 of 17/06/2004
22/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/206/II/11
03/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/206/II/12
02/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/206/II/13
27/03/2009 Centralised - Renewal EMEA/H/C/206/R/15 (2009)2290 of 25/03/2009
01/04/2009 Centralised - Variation EMEA/H/C/206/IA/17
Updated with Decision(2009)8507 of 28/10/2009
02/11/2009 Centralised - Variation (2009)8507 of 28/10/2009
19/05/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/206/II/18/G
01/08/2011 Centralised - Variation EMEA/H/C/206/II/20 (2011)5600 of 27/07/2011
15/11/2012 Centralised - Variation EMEA/H/C/206/II/24
Updated with Decision(2013)8330 of 20/11/2013
22/11/2013 Centralised - Yearly update (2013)8330 of 20/11/2013
06/12/2013 Centralised - Notification EMEA/H/C/206/N/26