Iqirvo

Medicinal product

(Invented) name

Iqirvo

Active substance (s)

Elafibranoras

Strength

80 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A05AX06, elafibranor

Marketing authorisation holder

Ipsen Pharma, Prancūzija

Date of authorisation

2024-09-19

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

Tabletėje yra:	1 vnt.
Elafibranoras	80 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
115192	101301	1101301	buteliukas	N30		Receptinis	EU/1/24/1855/001	Netiekiama	-	-	No	-	-
118218	104326	1104326	buteliukas	N90 (3×1)		Receptinis	EU/1/24/1855/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-19	Registruotas