Ambrisentan Viatris

Medicinal product

(Invented) name

Ambrisentan Viatris

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

Viatris Limited, Airija

Date of authorisation

2019-06-20

Date of renewal

Documents

Ambrisentan Mylan paciento kortele.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	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
101982	88084	1088084	lizdinė plokštelė	N30		Receptinis	EU/1/19/1368/001	Netiekiama	-	-	No	-	-
101983	88085	1088085	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/19/1368/002	Netiekiama	-	-	No	-	-
103512	89614	1089614	dalomoji lizdinė plokštelė	N60x1		Receptinis	EU/1/19/1368/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-06-20	Registruotas