Is Tirofiban registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Tirofiban, including AGGRASTAT 0.25MG/ML I.V. VIAL (0.25 mg/ml, Concentrate for solution for infusion, SAR 980.15); AGRIPLAT 12.5 MG SOLUTION FOR INFUSION (0.25 mg/ml, Concentrate for solution for infusion, SAR 796.40); Fibrosta (250 µ/ml, Concentrate for solution for infusion, SAR 753.20).

Is Tirofiban approved by the US FDA?

Drugs@FDA lists 7 application product lines for Tirofiban, including AGGRASTAT (Prescription); AGGRASTAT (Prescription); TIROFIBAN HYDROCHLORIDE (Prescription); TIROFIBAN HYDROCHLORIDE (Prescription); TIROFIBAN HYDROCHLORIDE (Prescription).

Are there safety signals or safety updates for Tirofiban?

US FDA: 2 entries (latest 2019-05-16).

Active substance

Tirofiban

SFDA 4
US FDA 7
Health Canada 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
AGGRASTAT 0.25MG/ML I.V. VIAL	0.25 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 980.15	Generic · Prescription	Algorithm SAL	Valid
AGRIPLAT 12.5 MG SOLUTION FOR INFUSION	0.25 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 796.40	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Fibrosta	250 µ/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 753.20	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
AGGRASTAT 0.25MG\ML I.V VIAL	0.25 mg/ml	Injection · Intravenous use	1 Vial	SAR 1225.20	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by regulatory authority · Not Marketed

Indications — CHI Daman Drug Formulary

NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI)

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

Product	Strength	Form · route	Applicant	Status	First approved
AGGRASTAT	EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)	solution · injection	MEDICURE	Prescription	14 May 1998
AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML); EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	solution · intravenous	MEDICURE	Prescription	14 May 1998
TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	solution · intravenous	GLAND	Prescription	8 Apr 2021
TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML); EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	solution · intravenous	NEXUS	Prescription	7 Feb 2023
TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML); EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	solution · intravenous	EUGIA PHARMA	Prescription	1 May 2023
AGGRASTAT	EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)	injectable · injection	MEDICURE	Discontinued	14 May 1998
AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	solution · intravenous	MEDICURE	Discontinued	14 May 1998

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AGGRASTAT	02240706	12.5 MG / 250 ML	SOLUTION · INTRAVENOUS	CIPHER PHARMACEUTICALS INC

Safety signals and safety-related labeling changes

US FDA 16 May 2019 AGGRASTAT — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 16 May 2019 AGGRASTAT — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for tirofiban →

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.