Is Thrombin alfa registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Thrombin alfa, including RECOTHROM (5000 IU, Powder, SAR 354.75); RECOTHROM (20000 IU, Powder, SAR 1419.00).

Is Thrombin alfa authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Thrombin alfa.

Active substance

Thrombin alfa

SFDA 2
EMA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
RECOTHROM	5000 IU	Powder · Topical	1 Vial	SAR 354.75	Biological · Prescription	BAXTER HEALTHCARE CORPORATION	Valid
RECOTHROM	20000 IU	Powder · Topical	1 Vial	SAR 1419.00	Biological · Prescription	BAXTER HEALTHCARE CORPORATION	Valid

EMA European Union — centrally authorised medicines

Recothrom Bayer Schering Pharma AG · Application withdrawn

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.