Is Clopidogrel registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 10 valid registrations of Clopidogrel, including CLOGREL 75 mg film-coated tablet (75 mg, Film-coated tablet, SAR 118.15); CLOPACIN 75mg film-coated tablets (75 mg, Film-coated tablet, SAR 118.15); CUPIDO (75 mg, Film-coated tablet, SAR 115.55); Devasc (75 mg, Tablet, SAR 118.15); Oneclapz (75 mg, Film-coated tablet, SAR 118.15).

Is Clopidogrel approved by the US FDA?

Drugs@FDA lists 26 application product lines for Clopidogrel, including PLAVIX (Prescription); CLOPIDOGREL BISULFATE (Prescription); CLOPIDOGREL BISULFATE (Prescription); CLOPIDOGREL BISULFATE (Prescription); CLOPIDOGREL BISULFATE (Prescription).

Is Clopidogrel authorised in the European Union?

EMA lists 14 centrally authorised medicines containing Clopidogrel: Iscover, Plavix, Clopidogrel Zentiva (previously Clopidogrel Winthrop), Clopidogrel Teva (hydrogen sulphate), Grepid, Clopidogrel Krka d.d. (previously Zopya), Clopidogrel Taw Pharma (previously Clopidogrel Mylan), Clopidogrel BGR (previously Zylagren).

Is Clopidogrel on the WHO Model List of Essential Medicines?

Yes — 12.5.1. Anti-platelet medicines (core list): Acute ischaemic heart disease; Presence of coronary angioplasty implant or graft.

Are there safety signals or safety updates for Clopidogrel?

EMA PRAC: 10 entries; US FDA: 1 entry; MHRA: 1 entry (latest 2022-09-16).

Active substance

Clopidogrel

SFDA 15
US FDA 26
EMA 29
Health Canada 19
US price lines 3
NHS prices 2
WHO EML 1
Safety 12

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CLOGREL 75 mg film-coated tablet	75 mg	Film-coated tablet · Oral use	30 Blister	SAR 118.15	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
CLOPACIN 75mg film-coated tablets	75 mg	Film-coated tablet · Oral use	28 Blister	SAR 118.15	Generic · Prescription	ACINO PHARMA AG	Valid
CUPIDO	75 mg	Film-coated tablet · Oral use	30 Blister	SAR 115.55	Generic · Prescription	APOTEX	Valid
Devasc	75 mg	Tablet · Oral use	30 Blister	SAR 118.15	Generic · Prescription	Saudi Amarox	Valid
Oneclapz	75 mg	Film-coated tablet · Oral use	30 Blister	SAR 118.15	Generic · Prescription	ALTAIF PHARMACEUTICALS COMPANY	Valid
PALETA 75mg film-coated tablets	75 mg	Film-coated tablet · Oral use	28 Blister	SAR 91.90	Generic · Prescription	SPIMACO ADDWAEIH	Valid
PLAVIX 75 MG TABLET	75 mg	Film-coated tablet · Oral use	28 Blister	SAR 230.00	NCE · Prescription	SANOFI WINTHROP INDUSTRIE	Valid
Pedovex	75 mg	Film-coated tablet · Oral use	30 Blister	SAR 173.70	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Ravixa	75 mg	Film-coated tablet · Oral use	30 Blister	SAR 158.00	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
clopidogrel ALH	75 mg	Tablet · Oral use	30 Blister	SAR 118.15	Generic · Prescription	Alhobail Pharm	Valid
PEEVO	75 mg	Film-coated tablet · Oral use	28 Blister	SAR 118.15	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Suspended
CARDLET 75 mg film-coated tablet	75 mg	Film-coated tablet · Oral use	30 Blister	SAR 118.15	Generic · Prescription	Abbott Laboratories GmbH	Withdrawn by regulatory authority · Not Marketed
CLOPEX 75 mg film-coated tablet	75 mg	Film-coated tablet · Oral use	28 Blister	SAR 145.90	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Withdrawn by regulatory authority · Not Marketed
PEDOVEX 75 MG F.C. TABLETS	75 mg	Film-coated tablet · Oral use	30 Blister	SAR 173.70	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by regulatory authority · Not Marketed
VIDAPART 75 mg film-coated tablets	75 mg	Film-coated tablet · Oral use	28 Blister	SAR 80.95	Generic · Prescription	ACTAVIS	Withdrawn by regulatory authority · Not Marketed

Indications — CHI Daman Drug Formulary

CORONARY ARTERY DISEASE; ISCHEMIC STROKE; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); POLYCYTHEMIA VERA - HEADACHE/TINNITUS; RAYNAUD'S PHENOMENON; ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI)

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

Product	Strength	Form · route	Applicant	Status	First approved
PLAVIX	EQ 75MG BASE; EQ 300MG BASE	tablet · oral	SANOFI AVENTIS US	Prescription	17 Nov 1997
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	DR REDDYS	Prescription	14 Jan 2008
CLOPIDOGREL BISULFATE	EQ 75MG BASE; EQ 300MG BASE	tablet · oral	APOTEX INC	Prescription	17 May 2012
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	TEVA	Prescription	17 May 2012
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	PHARMAZONE	Prescription	17 May 2012
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	AUROBINDO PHARMA LTD	Prescription	17 May 2012
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	TORRENT PHARMS LTD	Prescription	17 May 2012
CLOPIDOGREL BISULFATE	EQ 300MG BASE; EQ 75MG BASE	tablet · oral	DR REDDYS LABS LTD	Prescription	17 May 2012
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	MACLEODS PHARMS	Prescription	10 Feb 2014
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	AMNEAL PHARMS	Prescription	11 Apr 2014
CLOPIDOGREL BISULFATE	EQ 75MG BASE; EQ 300MG BASE	tablet · oral	SCIEGEN PHARMS	Prescription	15 Sep 2014
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	RISING	Prescription	2 Feb 2017
CLOPIDOGREL BISULFATE	EQ 75MG BASE; EQ 300MG BASE	tablet · oral	PRINSTON INC	Prescription	7 May 2018
CLOPIDOGREL BISULFATE	EQ 75MG BASE; EQ 300MG BASE	tablet · oral	PURACAP LABS BLU	Prescription	17 Jul 2020
CLOPIDOGREL BISULFATE	EQ 75MG BASE; EQ 300MG BASE	tablet · oral	HETERO LABS LTD V	Prescription	4 Aug 2023
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	ALKEM LABS LTD	Prescription	8 Dec 2023
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	MSN	Prescription	20 Sep 2024
CLOPIDOGREL BISULFATE	EQ 75MG BASE; EQ 300MG BASE	tablet · oral	RISING	Discontinued	17 May 2012
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	SUN PHARM	Discontinued	17 May 2012
CLOPIDOGREL BISULFATE	EQ 300MG BASE	tablet · oral	ANI PHARMS	Discontinued	17 May 2012
CLOPIDOGREL BISULFATE	EQ 300MG BASE	tablet · oral	ANI PHARMS	Discontinued	17 May 2012
CLOPIDOGREL BISULFATE	EQ 75MG BASE; EQ 300MG BASE	tablet · oral	CHARTWELL RX	Discontinued	14 Aug 2012
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	ZYDUS LIFESCIENCES	Discontinued	10 Oct 2012
CLOPIDOGREL BISULFATE	EQ 75MG BASE; EQ 300MG BASE	tablet · oral	ACCORD HLTHCARE	Discontinued	27 Mar 2013
CLOPIDOGREL BISULFATE	EQ 75MG BASE	tablet · oral	ACTAVIS TOTOWA	Discontinued	28 May 2013

1 more — full table

EMA European Union — centrally authorised medicines

Iscover Sanofi Winthrop Industrie · Authorised · authorised 14 Jul 1998 · ATC B01AC04

Therapeutic indication (EMA)

Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)Clopidogrel in combination with ASA is indicated in: Adult patients with moderate to high-risk TIA (ABCD2 score ?4) or minor IS (NIHSS ?3) within 24 hours of either the TIA or IS event. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Plavix Sanofi Winthrop Industrie · Authorised · authorised 15 Jul 1998 · ATC B01AC04

Therapeutic indication (EMA)

Secondary prevention of atherothrombotic events Clopidogrel is indicated in: adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease; adult patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS) Clopidogrel in combination with ASA is indicated in: Adult patients with moderate to high-risk TIA (ABCD2 score ?4) or minor IS (NIHSS ?3) within 24 hours of either the TIA or IS event. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Clopidogrel Zentiva (previously Clopidogrel Winthrop) Zentiva k.s. · Authorised · authorised 15 Jul 2008 · ATC B01AC04

Therapeutic indication (EMA)

Secondary prevention of atherothrombotic events Clopidogrel is indicated in: adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease; adult patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5.1.

Clopidogrel Teva (hydrogen sulphate) Teva Pharma B.V. · Authorised · authorised 27 Jul 2009 · ATC B01AC04

Therapeutic indication (EMA)

Secondary prevention of atherothrombotic eventsClopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome:- Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillationIn adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Grepid Pharmathen S.A. · Authorised · authorised 27 Jul 2009 · ATC B01AC04

Therapeutic indication (EMA)

Prevention of atherothrombotic events Clopidogrel is indicated in: adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease; adult patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Clopidogrel Krka d.d. (previously Zopya) Norpharm Regulatory Services Ltd · Authorised · authorised 20 Sep 2009 · ATC B01AC03

Therapeutic indication (EMA)

Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35days), ischaemic stroke (from 7days until less than 6months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Clopidogrel Taw Pharma (previously Clopidogrel Mylan) Taw Pharma (Ireland) Limited · Authorised · authorised 21 Sep 2009 · ATC B01AC04

Therapeutic indication (EMA)

Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. In patients with moderate to high-risk Transient Ischaemic Attack (TIA) or minor Ischaemic Stroke (IS) Clopidogrel in combination with ASA is indicated in: Adult patients with moderate to high-risk TIA (ABCD2 score ?4) or minor IS (NIHSS ?3) within 24 hours of either the TIA or IS event. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5.1.

Clopidogrel BGR (previously Zylagren) Biogaran · Authorised · authorised 21 Sep 2009 · ATC B01AC03

Therapeutic indication (EMA)

Prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

Clopidogrel Krka Krka, d.d., Novo mesto · Authorised · authorised 23 Sep 2009 · ATC B01AC04

Therapeutic indication (EMA)

Clopidogrel TAD Tad Pharma GmbH · Authorised · authorised 23 Sep 2009 · ATC B01AC04

Therapeutic indication (EMA)

Zyllt Krka, d.d., Novo mesto · Authorised · authorised 28 Sep 2009 · ATC B01AC04

Therapeutic indication (EMA)

Prevention Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation: - In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Clopidogrel Viatris (previously Clopidogrel Taw Pharma) Viatris Limited · Authorised · authorised 16 Oct 2009 · ATC B01AC04

Therapeutic indication (EMA)

Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome. Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. In patients with moderate to high-risk Transient Ischaemic Attack (TIA) or minor Ischaemic Stroke (IS) Clopidogrel in combination with ASA is indicated in: Adult patients with moderate to high-risk TIA (ABCD2 score ?4) or minor IS (NIHSS ?3) within 24 hours of either the TIA or IS event. Prevention of atherothrombotic and thromboembolic events in atrial fibrillation: In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5.1.

Clopidogrel HCS HCS bvba · Authorised · authorised 28 Oct 2010 · ATC B01AC04

Therapeutic indication (EMA)

Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillationIn adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5.1.

Clopidogrel ratiopharm Teva B.V. · Authorised · authorised 18 Feb 2015 · ATC B01AC04

Therapeutic indication (EMA)

Secondary prevention of atherothrombotic events Clopidogrel is indicated in: Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Adult patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. Prevention of atherothrombotic and thromboembolic events in atrial fibrillationIn adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.

Clopidogrel Teva Pharma Teva Pharma B.V. · Application withdrawn

Clopidogrel BMS Bristol-Myers Squibb Pharma EEIG · Withdrawn · authorised 16 Jul 2008 · ATC B01AC04

Therapeutic indication (EMA)

Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: - Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. - Patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

Clopidogrel DURA Mylan dura GmbH · Withdrawn · authorised 21 Jul 2009 · ATC B01AC04

Therapeutic indication (EMA)

Clopidogrel 1A Pharma Acino Pharma GmbH · Withdrawn · authorised 28 Jul 2009 · ATC B01AC04

Therapeutic indication (EMA)

Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. Patients suffering from acute coronary syndrome: - Non ST segment elevation acute coronary syndrome (unstable angina or non Q wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. For further information please refer to section 5.1.

Clopidogrel Hexal Acino Pharma GmbH · Withdrawn · authorised 28 Jul 2009 · ATC B01AC04

Therapeutic indication (EMA)

Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease; patients suffering from acute coronary syndrome: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. For further information please refer to section 5.1.

Clopidogrel ratiopharm GmbH Archie Samiel s.r.o. · Withdrawn · authorised 28 Jul 2009 · ATC B01AC04

Therapeutic indication (EMA)

Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease; patients suffering from acute coronary syndrome: non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q wave-myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA); ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

9 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AG-CLOPIDOGREL	02431971	75 MG	TABLET · ORAL	ANGITA PHARMA INC.
APO-CLOPIDOGREL	02252767	75 MG	TABLET · ORAL	APOTEX INC
APO-CLOPIDOGREL	02398591	300 MG	TABLET · ORAL	APOTEX INC
AURO-CLOPIDOGREL	02416387	75 MG	TABLET · ORAL	AURO PHARMA INC
BIO-CLOPIDOGREL	02444895	75 MG	TABLET · ORAL	BIOMED PHARMA
CLOPIDOGREL	02385813	75 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
CLOPIDOGREL	02394820	75 MG	TABLET · ORAL	PRO DOC LIMITEE
CLOPIDOGREL	02400553	75 MG	TABLET · ORAL	SANIS HEALTH INC
JAMP-CLOPIDOGREL	02415550	75 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
M-CLOPIDOGREL	02502283	75 MG	TABLET · ORAL	MANTRA PHARMA INC
MAR-CLOPIDOGREL	02422255	75 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MINT-CLOPIDOGREL	02408910	75 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
NRA-CLOPIDOGREL	02482037	75 MG	TABLET · ORAL	NORA PHARMA INC
PLAVIX	02238682	75 MG	TABLET · ORAL	SANOFI-AVENTIS CANADA INC
PMS-CLOPIDOGREL	02348004	75 MG	TABLET · ORAL	PHARMASCIENCE INC
RIVA-CLOPIDOGREL	02388529	75 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
SPC-CLOPIDOGREL	02379813	75 MG	TABLET · ORAL	SUN PHARMA CANADA INC
TEVA-CLOPIDOGREL	02293161	75 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-CLOPIDOGREL	02388065	300 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CLOPIDOGREL 300 MG TABLET	$5.29107	per EA	23 Sep 2026
US NADAC	CLOPIDOGREL 75 MG TABLET	$0.04719	per EA	23 Sep 2026
US NADAC	PLAVIX 75 MG TABLET	$8.22931	per EA	23 Sep 2026
NHS Drug Tariff	Clopidogrel 300mg tablets	£142.54	30 tablet	1 Oct 2026
NHS Drug Tariff	Clopidogrel 75mg tablets	£0.93	28 tablet	1 Oct 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)

12.5.1. Anti-platelet medicines · core
Acute ischaemic heart disease; Presence of coronary angioplasty implant or graft
Oral > Solid: 75 mg; 300 mg

Safety signals and safety-related labeling changes

US FDA 16 Sep 2022 PLAVIX — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 16 May 2019 PRAC signal: Interaction with boosted antiviral human immunodeficiency virus (HIV) therapy leading to insufficient inhibition of platelet aggregation
Action for MAH: update of the product information: Yes
EMA PRAC 29 Nov 2018 PRAC signal: Interaction with boosted antiviral human immunodeficiency virus (HIV) therapy leading to insufficient inhibition of platelet aggregation
Action for MAH: update of the product information: No
EMA PRAC 8 Mar 2018 PRAC signal: Insulin autoimmune syndrome
Action for MAH: update of the product information: No
EMA PRAC 11 Jun 2015 PRAC signal: Safety of dual antiplatelet therapy
Action for MAH: update of the product information: No
EMA PRAC 10 Apr 2015 PRAC signal: Drug interaction with grapefruit juice leading to potential impairment of therapeutic efficacy
Action for MAH: update of the product information: No
EMA PRAC 9 Jan 2015 PRAC signal: Safety of dual antiplatelet therapy
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Clopidogrel: risk of acquired haemophilia
Reports of acquired haemophilia have been received in association with clopidogrel.
EMA PRAC 7 Mar 2013 PRAC signal: Acquired haemophilia A
Action for MAH: update of the product information: Yes
EMA PRAC 7 Mar 2013 PRAC signal: Cross-reactivity between clopidogrel and ticlopidine among patients with previous allergic and/or haematologic reactions to one of these products
Action for MAH: update of the product information: Yes
EMA PRAC 10 Jan 2013 PRAC signal: Eosinophilic pneumonia
Action for MAH: update of the product information: Yes
EMA PRAC 5 Sep 2012 PRAC signal: Eosinophilic pneumonia
Action for MAH: update of the product information: No

All safety entries for clopidogrel →

Combinations containing Clopidogrel

Acetylsalicylic acid + clopidogrel

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.