Evicel (human fibrinogen;human thrombin)
- Region
- 🇪🇺 EU
- Active substance
- human fibrinogen;human thrombin
- Company
- Omrix Biopharmaceuticals N. V.
- Status
- Withdrawn
- Therapeutic area
- Hemostasis, Surgical
- CHMP opinion
- Thu 24 Jul 2008
- EU approval
- Sun 05 Oct 2008
- Application
- EMEA/H/C/000898
- ATC
- B02BC
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 TachoSil Authorised · Corza Medical GmbH
- 🇪🇺 VeraSeal Authorised · Instituto Grifols, S.A.
- 🇪🇺 Raplixa Withdrawn · Mallinckrodt Pharmaceuticals Ireland Limited
- 🇪🇺 Evarrest Withdrawn · Omrix Biopharmaceuticals N. V.
- 🇪🇺 Veraseal Application withdrawn · Instituto Grifols, S.A.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.