Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: EVARREST   
Auth. number : EU/1/13/868
INN : 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 - Combinations
(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, B-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 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
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