Ambrisentan AOP

Medicinal product

(Invented) name

Ambrisentan AOP

Active substance (s)

Ambrisentanas

Strength

10 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

AOP Orphan Pharmaceuticals GmbH, Austrija

Date of authorisation

2020-12-22

Date of renewal

2025-03-03

Documents

4654-55_pakuotes lapelis_2025-03-03.docx

Ambrisentan AOP paciento kortele.pdf

4654-55_Ambrisentan AOP_perr2025-03-03.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4787/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ambrisentanas	10 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
105526	91626	1091626	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/20/4655/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-03	Perregistruotas
2020-12-22	Registruotas