Is Aprotinin approved by the US FDA?

Drugs@FDA lists 1 application product line for Aprotinin, including TRASYLOL (Discontinued).

Is Aprotinin authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Aprotinin, including APROTININ 10,000 KIU/ML INJECTION BP.

Active substance

Aprotinin

US FDA 1
UK MHRA 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
TRASYLOL	10,000KIU/ML	injectable · injection	BAYER HLTHCARE	Discontinued	29 Dec 1993

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
APROTININ 10,000 KIU/ML INJECTION BP	PL 40621/0020	NORDIC GROUP BV	POM

Combinations containing Aprotinin

Aprotinin + calcium chloride + human fibrinogen + human thrombin

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.