Evlarco

Opinion

Human

Details

EMA number	EMEA/H/C/006517
ATC code	C10B
Authorisation	-
Revision	-

EMA page

Therapeutic indication

Treatment of primary hypercholesterolaemia or mixed dyslipidaemia.

MeSH: Hypercholesterolemia;Dyslipidemias

Group: Lipid modifying agents

Active substances

ezetimibe obicetrapib hemicalcium

Marketing Authorisation Holder

A. Menarini International Licensing S.A.

MAH

🇺🇸 Also approved in the US (FDA)

VYTORIN — ORGANON, approved 2024-03-28 (NDA021687).

Most reported adverse events (US / FAERS)

58,467 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.

fatigue

5,567

nausea

5,309

myalgia

5,072

drug ineffective

4,429

diarrhoea

🇺🇸 Also approved in the US (FDA)

VYTORIN — ORGANON, approved 2024-03-28 (NDA021687).

Most reported adverse events (US / FAERS)

58,467 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.

fatigue

5,567

nausea

5,309

myalgia

5,072

drug ineffective

4,429

diarrhoea

4,420

dizziness

4,187

dyspnoea

4,001

headache

3,839

arthralgia

3,515

pain

3,514

asthenia

3,440

pain in extremity

2,949

fall

2,836

vomiting

2,785

malaise

2,604