Is Alteplase 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 Alteplase, including ACTILYSE SET(2VLS+2SOLV&INFSET) (50 mg, Powder and solvent for solution for injection, SAR 5336.10).

Is Alteplase approved by the US FDA?

Drugs@FDA lists 2 application product lines for Alteplase, including ACTIVASE (Prescription); CATHFLO ACTIVASE (Prescription).

Is Alteplase on the WHO Model List of Essential Medicines?

Yes — 12.5.2. Thrombolytic medicines (complementary list): Cerebral ischaemic stroke.

Are there safety signals or safety updates for Alteplase?

US FDA: 2 entries (latest 2018-02-28).

Active substance

Alteplase

SFDA 1
US FDA 2
Health Canada 1
US price lines 1
WHO EML 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ACTILYSE SET(2VLS+2SOLV&INFSET)	50 mg	Powder and solvent for solution for injection · Intravenous use	2 Vial	SAR 5336.10	Biological · Prescription	BOEHRINGER INGELHEIM	Valid

Indications — CHI Daman Drug Formulary

ISCHEMIC STROKE; PULMONARY EMBOLISM; 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
ACTIVASE	100MG/VIAL; 50MG/VIAL	vial · single-use	GENENTECH	Prescription	13 Nov 1987
CATHFLO ACTIVASE	2MG/VIAL	vial	GENENTECH	Prescription	13 Nov 1987

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CATHFLO	02245859	2 MG / VIAL	POWDER FOR SOLUTION · INSTILLATION	HOFFMANN-LA ROCHE LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CATHFLO ACTIVASE 2 MG VIAL	$186.3796	per EA	1 Jan 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

12.5.2. Thrombolytic medicines · complementary
Cerebral ischaemic stroke
Parenteral > General injections > IV: 10 mg in vial powder for injection; 20 mg in vial powder for injection; 50 mg in vial powder for injection

Safety signals and safety-related labeling changes

US FDA 28 Feb 2018 ACTIVASE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
US FDA 28 Feb 2018 CATHFLO ACTIVASE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions

All safety entries for alteplase →

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.