Evarrest (human fibrinogen;human thrombin)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- human fibrinogen;human thrombin
- Company
- Omrix Biopharmaceuticals N. V.
- Status
- Withdrawn
- Therapeutic area
- Hemostasis
- EU approval
- Wed 25 Sep 2013
- Designations
- Additional monitoring
- Application
- EMEA/H/C/002515
- ATC
- B02BC30
- Official record
- www.ema.europa.eu
Indication
Supportive treatment in adult surgery where standard surgical techniques are insufficient (see section 5.1): - for improvement of haemostasis.
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.
- 🇪🇺 Evicel Withdrawn · Omrix Biopharmaceuticals N. V.
- 🇪🇺 Raplixa Withdrawn · Mallinckrodt Pharmaceuticals Ireland Limited
- 🇪🇺 Veraseal Application withdrawn · Instituto Grifols, S.A.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.