Evicel
Withdrawn
This medicine's authorisation has been withdrawn
human fibrinogen / human thrombin
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 5 July 2024, the European Commission withdrew the marketing authorisation for Evicel (human fibrinogen / human thrombin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Omrix Biopharmaceuticals N. V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Evicel was granted marketing authorisation in the EU on 6 October 2008 for supportive treatment in surgery, improvement of haemostasis and suture support for haemostasis in vascular surgery. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2013.
Evicel is identical to TachoSil and VeraSeal, which are authorised in the EU for supportive treatment in surgery, improvement of haemostasis and suture support for haemostasis in vascular surgery.
The European Public Assessment Report (EPAR) for Evicel is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:II/0099
16/03/2023
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
- Evicel
- Active substance
- human fibrinogen
- human thrombin
- International non-proprietary name (INN) or common name
- human fibrinogen
- human thrombin
- Therapeutic area (MeSH)
- Hemostasis, Surgical
- Anatomical therapeutic chemical (ATC) code
- B02BC
Pharmacotherapeutic group
AntihemorrhagicsTherapeutic indication
Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.
Evicel is also indicated as suture support for haemostasis in vascular surgery.
Assessment history
News on Evicel
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