Raplixa (human fibrinogen;human thrombin)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- human fibrinogen;human thrombin
- Company
- Mallinckrodt Pharmaceuticals Ireland Limited
- Status
- Withdrawn
- Therapeutic area
- Hemostasis, Surgical
- EU approval
- Thu 19 Mar 2015
- Designations
- Additional monitoring
- Application
- EMEA/H/C/002807
- ATC
- B02BC30
- Official record
- www.ema.europa.eu
Indication
Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis. Raplixa must be used in combination with an approved gelatin sponge. Raplixa is indicated in adults over 18 years of age.
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- 🇪🇺 Evicel Withdrawn · Omrix Biopharmaceuticals N. V.
- 🇪🇺 Evarrest Withdrawn · Omrix Biopharmaceuticals N. V.
- 🇪🇺 Veraseal Application withdrawn · Instituto Grifols, S.A.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.