Vazkepa

Medicinal product

(Invented) name

Vazkepa

Active substance (s)

Ikozapento etilas

Strength

998 mg

Pharmaceutical form

minkštosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C10AX06, Omega-3-triglycerides incl. other esters and acids

Marketing authorisation holder

Amarin Pharmaceuticals Ireland Limited, Airija

Date of authorisation

2021-03-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, soft	1 vnt.
Ikozapento etilas	998 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
106223	92324	1092324	buteliukas	N120		Receptinis	EU/1/20/1524/001	Netiekiama	-	-	No	-	-
106224	92325	1092325	dalomoji lizdinė plokštelė	N4x2		Receptinis	EU/1/20/1524/002	Netiekiama	-	-	No	-	-
107931	94036	1094036	buteliukas	N360 (3×120)		Receptinis	EU/1/20/1524/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-26	Registruotas