Bylvay

Medicinal product

(Invented) name

Bylvay

Active substance (s)

Odeviksibatas

Strength

400 µg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A05AX05, odevixibat

Marketing authorisation holder

Ipsen Pharma, Prancūzija

Date of authorisation

2021-07-16

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, hard	1 vnt.
Odeviksibatas	400 µg

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
106941	93044	1093044	buteliukas	N30		Receptinis	EU/1/21/1566/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-07-16	Registruotas