Ambrisentan Zentiva

Medicinal product

(Invented) name

Ambrisentan Zentiva

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

Zentiva k.s., Čekija

Date of authorisation

2020-12-22

Date of renewal

2025-05-09

Documents

Ambrisentan paciento kortele.pdf

4658_59_pakuotes lapelis_2025-05-09.docx

4658_59_Ambr_Zentiva_perr2025-05-09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4898/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	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
105542	91642	1091642	lizdinė plokštelė	N10		Receptinis	LT/1/20/4658/001	Netiekiama	-	-	No	-	-
105543	91643	1091643	lizdinė plokštelė	N30		Receptinis	LT/1/20/4658/002	Netiekiama	-	-	No	-	-
105544	91644	1091644	dalomoji lizdinė plokštelė	N10×1		Receptinis	LT/1/20/4658/003	Netiekiama	-	-	No	-	-
105545	91645	1091645	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/20/4658/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-05-09	Perregistruotas
2020-12-22	Registruotas