DuoCover

Application withdrawnHuman

Details

EMA number	EMEA/H/C/000875
ATC code	-
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Not specified

MeSH: Vascular Surgical Procedures;Peripheral Vascular Diseases;Myocardial Infarction;Acute Coronary Syndrome

Active substances

clopidogrel acetylsalicylic acid

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG

MAH

🇺🇸 Also approved in the US (FDA)

CLOPIDOGREL — PURACAP LABS BLU, approved 2022-07-27 (ANDA213351).

Most reported adverse events (US / FAERS)

118,111 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

dyspnoea

10,785

myocardial infarction

10,186

fatigue

9,283

gastrointestinal haemorrhage

8,712

🇺🇸 Also approved in the US (FDA)

CLOPIDOGREL — PURACAP LABS BLU, approved 2022-07-27 (ANDA213351).

Most reported adverse events (US / FAERS)

118,111 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

dyspnoea

10,785

myocardial infarction

10,186

fatigue

9,283

gastrointestinal haemorrhage

8,712

nausea

8,560

dizziness

8,383

diarrhoea

8,033

drug ineffective

7,947

asthenia

7,329

fall

7,117

cerebrovascular accident

6,790

anaemia

6,666

death

6,502

headache

5,939

pain

5,879