Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: EVARREST
Auth. number : EU/1/13/868
Active substance : Human fibrinogen/Human thrombin
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B02 - Antihemorrhagics
Pharmacological subgroup: B02B - Vitamin K and other hemostatics
Chemical subgroup: B02BC - Local hemostatics
Chemical substance: B02BC30 - diphtheria-hemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B
(See WHO ATC Index)
Indication: EVARREST is indicated in adults for supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis
Marketing Authorisation Holder: Omrix Biopharmaceuticals N.V.
Leonardo Da Vincilaan 15, 1831 Diegem, België
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
27/09/2013 Centralised - Authorisation EMEA/H/C/2515 (2013)6344 of 25/09/2013
20/02/2014 Centralised - Variation EMEA/H/C/2515/II/1
Updated with Decision(2015)1312 of 19/02/2015
20/11/2014 Centralised - Variation EMEA/H/C/2515/II/2/G
Updated with Decision(2015)1312 of 19/02/2015
23/02/2015 Centralised - Yearly update (2015)1312 of 19/02/2015
02/03/2015 Centralised - Notification EMEA/H/C/2515/N/9
Updated with Decision(2016)6236 of 22/09/2016
24/09/2015 Centralised - Variation EMEA/H/C/2515/II/12/G
Updated with Decision(2016)6236 of 22/09/2016
26/09/2016 Centralised - Yearly update (2016)6236 of 22/09/2016
31/03/2017 Centralised - 2-Monthly update EMEA/H/C/2515/II/27/G (2017) 2219 of 29/03/2017
17/11/2017 Centralised - Withdrawal (2017) 7764 of 15/11/2017