Is Eptifibatide 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 Eptifibatide, including Eptifibatide Hainan (0.75 mg/ml, Solution for injection, SAR 1522.35).

Is Eptifibatide approved by the US FDA?

Drugs@FDA lists 17 application product lines for Eptifibatide, including EPTIFIBATIDE (Prescription); EPTIFIBATIDE (Prescription); EPTIFIBATIDE (Prescription); EPTIFIBATIDE (Prescription); EPTIFIBATIDE (Prescription).

Is Eptifibatide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Eptifibatide: Eptifibatide Accord.

Are there safety signals or safety updates for Eptifibatide?

US FDA: 1 entry (latest 2021-02-28).

Active substance

Eptifibatide

SFDA 1
US FDA 17
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
Eptifibatide Hainan	0.75 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 1522.35	Generic · Prescription	Hainan Poly Pharm. Co., Ltd.	Valid

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
EPTIFIBATIDE	2MG/ML	injectable · injection	TEVA PHARMS USA	Prescription	12 Jun 2015
EPTIFIBATIDE	2MG/ML; 75MG/100ML	injectable · injection	EUGIA PHARMA	Prescription	8 Dec 2015
EPTIFIBATIDE	2MG/ML; 75MG/100ML	injectable · injection	SAGENT PHARMS INC	Prescription	7 Mar 2018
EPTIFIBATIDE	2MG/ML; 75MG/100ML	injectable · injection	MYLAN LABS LTD	Prescription	20 Jul 2018
EPTIFIBATIDE	75MG/100ML	injectable · injection	BAXTER HLTHCARE CORP	Prescription	23 Nov 2018
EPTIFIBATIDE	2MG/ML; 75MG/100ML	injectable · injection	HAINAN POLY	Prescription	25 Jan 2019
EPTIFIBATIDE	2MG/ML; 75MG/100ML	injectable · injection	QUAGEN	Prescription	7 Sep 2021
EPTIFIBATIDE	2MG/ML; 75MG/100ML	injectable · injection	MEITHEAL	Prescription	9 May 2024
INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	MSD SUB MERCK	Discontinued	18 May 1998
EPTIFIBATIDE	75MG/100ML	injectable · injection	TEVA PHARMS USA	Discontinued	5 Jun 2015
EPTIFIBATIDE	2MG/ML; 75MG/100ML	injectable · injection		Discontinued	8 Dec 2016
EPTIFIBATIDE	2MG/ML; 75MG/100ML	injectable · injection	RISING	Discontinued	18 Apr 2017
EPTIFIBATIDE	2MG/ML; 75MG/100ML	injectable · injection	ACCORD HLTHCARE	Discontinued	6 Nov 2017
EPTIFIBATIDE	2MG/ML	injectable · injection	BAXTER HLTHCARE CORP	Discontinued	23 Nov 2018
EPTIFIBATIDE	2MG/ML	injectable · injection	USV	Discontinued	11 Mar 2019
EPTIFIBATIDE	2MG/ML; 75MG/100ML	injectable · injection	USV	Discontinued	14 Mar 2019
EPTIFIBATIDE	2MG/ML; 75MG/100ML	injectable · injection	HYBIO	Discontinued	20 Mar 2020

EMA European Union — centrally authorised medicines

Eptifibatide Accord Accord Healthcare S.L.U. · Authorised · authorised 11 Jan 2016 · ATC B01AC16

Therapeutic indication (EMA)

Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin. Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes. Patients most likely to benefit from Eptifibatide Accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty).

Integrilin GlaxoSmithKline Trading Services Limited · Withdrawn · authorised 1 Jul 1999 · ATC B01AC16

Therapeutic indication (EMA)

Integrilin is intended for use with acetylsalicylic acid and unfractionated heparin. Integrilin is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and / or elevated cardiac enzymes. Patients most likely to benefit from Integrilin treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early percutaneous transluminal coronary angioplasty (PTCA).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EPTIFIBATIDE INJECTION	02540819	0.75 MG / ML	SOLUTION · INTRAVENOUS	JUNO PHARMA CANADA INC.
EPTIFIBATIDE INJECTION	02540827	2 MG / ML	SOLUTION · INTRAVENOUS	JUNO PHARMA CANADA INC.

Safety signals and safety-related labeling changes

US FDA 28 Feb 2021 INTEGRILIN — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for eptifibatide →

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.