Volibris

Medicinal product

(Invented) name

Volibris

Active substance (s)

Ambrisentanas

Strength

5 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)

C02KX02, Ambrisentan

Marketing authorisation holder

GlaxoSmithKline (Ireland) Limited , Airija

Date of authorisation

2008-04-21

Date of renewal

Documents

Volibris paciento kortele.pdf

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

Film coated tablets	1 vnt.
Ambrisentanas	5 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
29630	32115	1032115	lizdinė plokštelė	N10		Receptinis	EU/1/08/451/001	Netiekiama	-	-	No	-	-
29631	32116	1032116	lizdinė plokštelė	N30		Receptinis	EU/1/08/451/002	Tiekiama	2025-05-26	-	No	-	-

Stadijos

Data	Stadija
2008-04-21	Registruotas