Ambrisentan Inteli

Medicinal product

(Invented) name

Ambrisentan Inteli

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

UAB Inteli Generics Nord, Lietuva

Date of authorisation

2024-10-22

Date of renewal

Documents

5621-22_pakuotes lapelis_2024-10-22.docx

5621-5622_Ambrisentan Inteli.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0271/001/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
115549	101656	1101656	lizdinė plokštelė	N30		Receptinis	LT/1/24/5621/001	Nepradėtas tiekti	-	-	No	-	-

Stadijos

Data	Stadija
2024-10-22	Registruotas