TachoSil (human fibrinogen;human thrombin)
- Region
- 🇪🇺 EU
- Active substance
- human fibrinogen;human thrombin
- Company
- Corza Medical GmbH
- Status
- Authorised
- Therapeutic area
- Hemostasis, Surgical
- EU approval
- Tue 08 Jun 2004
- Application
- EMEA/H/C/000505
- ATC
- B02BC30
- Official record
- www.ema.europa.eu
Indication
TachoSil is indicated in adults and children from 1 month of age for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. TachoSil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 VeraSeal Authorised · Instituto Grifols, S.A.
- 🇪🇺 Evicel Withdrawn · Omrix Biopharmaceuticals N. V.
- 🇪🇺 Raplixa Withdrawn · Mallinckrodt Pharmaceuticals Ireland Limited
- 🇪🇺 Evarrest Withdrawn · Omrix Biopharmaceuticals N. V.
- 🇪🇺 Veraseal Application withdrawn · Instituto Grifols, S.A.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.