Is Reteplase approved by the US FDA?

Drugs@FDA lists 1 application product line for Reteplase, including RETAVASE (Prescription).

Is Reteplase authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Reteplase.

Active substance

Reteplase

US FDA 1
EMA 2

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

Product	Strength	Form · route	Applicant	Status	First approved
RETAVASE	18.8MG/VIAL	vial	EKR THERAP	Prescription	6 May 1998

EMA European Union — centrally authorised medicines

Rapilysin Actavis Group PTC ehf · Withdrawn · authorised 29 Aug 1996 · ATC B01AD07

Therapeutic indication (EMA)

Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (AMI) symptoms.

Ecokinase Roche Registration Ltd. · Withdrawn · authorised 29 Aug 1996 · ATC B01AD07

Therapeutic indication (EMA)

Thrombolytic therapy of acute myocardial infarction

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.