Is Tenecteplase registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Tenecteplase, including METALYSE 10000 U I.V VIAL (10000 IU, Powder and solvent for solution for injection, SAR 5040.70).

Is Tenecteplase approved by the US FDA?

Drugs@FDA lists 1 application product line for Tenecteplase, including TNKASE (Prescription).

Is Tenecteplase authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tenecteplase: Metalyse.

Are there safety signals or safety updates for Tenecteplase?

US FDA: 1 entry (latest 2025-02-28).

Active substance

Tenecteplase

SFDA 1
US FDA 1
EMA 2
Health Canada 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
METALYSE 10000 U I.V VIAL	10000 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 5040.70	Biological · Prescription	BOEHRINGER INGELHEIM	Valid

Indications — CHI Daman Drug Formulary

ISCHEMIC STROKE; ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI); VENOUS THROMBOEMBOLISM DISEASE (VTE)-TREATMENT

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

Product	Strength	Form · route	Applicant	Status	First approved
TNKASE	50MG/VIAL	vial	GENENTECH	Prescription	2 Jun 2000

EMA European Union — centrally authorised medicines

Metalyse Boehringer Ingelheim International GmbH · Authorised · authorised 23 Feb 2001 · ATC B01AD11

Therapeutic indication (EMA)

Metalyse is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left-bundle-branch block within six hours after the onset of acute-myocardial-infarction symptoms. Metalyse is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.

Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KG Boehringer Ingelheim International GmbH · Withdrawn · authorised 23 Feb 2001 · ATC B01AD

Therapeutic indication (EMA)

Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KG is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TNKASE	02244826	50 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	HOFFMANN-LA ROCHE LIMITED
TNKASE	02562804	25 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 28 Feb 2025 TNKASE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for tenecteplase →

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.