SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| TachoSil sealant matrix | 5.5,2 mg,IU | Sealant matrix · Topical | 1 Box | SAR 1194.00 | Biological · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| VeraSeal | 80,500 mg/ml,IU/ml | Sealant matrix · Epilesional use | 2 Pre-filled syringe | SAR 465.20 | Biological · Prescription | Instituto Grifols, S.A | Valid |
| VeraSeal | 80,500 mg/ml,IU/ml | Sealant matrix · Epilesional use | 2 Pre-filled syringe | SAR 845.45 | Biological · Prescription | Instituto Grifols, S.A | Valid |
| VeraSeal | 80,500 mg/ml,IU/ml | Sealant matrix · Epilesional use | 2 Pre-filled syringe | SAR 1395.55 | Biological · Prescription | Instituto Grifols, S.A | Valid |
| VeraSeal | 80,500 mg/ml,IU/ml | Sealant matrix · Epilesional use | 2 Pre-filled syringe | SAR 1909.05 | Biological · Prescription | Instituto Grifols, S.A | Valid |
Indications — CHI Daman Drug Formulary
HEMOPHILIA A, HEMOPHILIA B, VON WILLEBRAND DISEASE
EMA European Union — centrally authorised medicines
TachoSil Corza Medical GmbH · Authorised · authorised 8 Jun 2004 · ATC B02BC30
Therapeutic indication (EMA)
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).
Veraseal Instituto Grifols, S.A. · Application withdrawn · ATC B02BC
Therapeutic indication (EMA)
Supportive treatment for improvement of haemostasis and as a suture support in vascular surgery
Evicel Omrix Biopharmaceuticals N. V. · Withdrawn · authorised 5 Oct 2008 · ATC B02BC
Therapeutic indication (EMA)
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.
Evarrest Omrix Biopharmaceuticals N. V. · Withdrawn · authorised 25 Sep 2013 · ATC B02BC30
Therapeutic indication (EMA)
Supportive treatment in adult surgery where standard surgical techniques are insufficient (see section 5.1): - for improvement of haemostasis.
Raplixa Mallinckrodt Pharmaceuticals Ireland Limited · Withdrawn · authorised 19 Mar 2015 · ATC B02BC30
Therapeutic indication (EMA)
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.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.