Amarin Corp Plc (AMRN)

[HDGabor]

Announcement is imminent

Product name: Vazkepa
EU number: EU/1/20/1524
Active substance: icosapent ethyl
Marketing Authorisation Holder: Amarin Pharmaceuticals Ireland Limited 88 Harcourt Street, Dublin 2, D02DK18, Ireland
ATC:
- Anatomical main group: C - Cardiovascular system
- Therapeutic subgroup: C10 - Lipid modifying agents
- Pharmacological subgroup: C10A - Lipid modifying agents, plain
- Chemical subgroup: C10AX - Other lipid modifying agents
(See WHO ATC Index)

Close date: 29 Mar 2021
Procedure type: Centralised - Authorisation
EMA number: EMEA/H/C/005398/0000
Decision number: (2021)2304 of 26 Mar 2021

4. KLINIKAI JELLEMZOK

4.1 Terápiás javallatok

A Vazkepa cardiovascularis események kockázatának csökkentésére javallott, sztatinnal kezelt, magas cardiovascularis kockázatnak kitett, emelkedett trigliceridszintu (= 150 mg/dl) felnott betegeknél, akiknél fennáll:
• diagnoztizált cardiovascularis betegség; vagy
• cukorbetegség, valamint legalább még egy cardiovascularis kockázati tényezo.

A cardiovascularis kockázati tényezokkel kapcsolatos adatokat és a cardiovascularis eseményekre gyakorolt hatással kapcsolatos vizsgálati eredményeket lásd az 5.1 pontban.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Vazkepa is indicated to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and
• established cardiovascular disease, or
• diabetes, and at least one other cardiovascular risk factor.

For study details including cardiovascular risk factors and results with respect to effects on cardiovascular events see section 5.1.

Best,
G

ps.: It was (t)odd that my DD was questioned ...