Ambrisentan Norameda

Medicinal product

(Invented) name

Ambrisentan Norameda

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 Norameda, Lietuva

Date of authorisation

2020-01-24

Date of renewal

2024-04-11

Documents

4499_4500 Ambrisentan Norameda PCS 2024 10 31, PL 2024 10 25.docx

Ambrisentan Norameda paciento kortele.pdf

4499_4500 Pakuotės lapelis 2024 10 25.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0397/001

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
103113	89214	1089214	lizdinė plokštelė	N10		Receptinis	LT/1/20/4499/001	Netiekiama	-	-	No	-	-
103114	89215	1089215	lizdinė plokštelė	N30		Receptinis	LT/1/20/4499/002	Netiekiama	-	-	No	-	-	Download
103115	89216	1089216	dalomoji lizdinė plokštelė	N10x1		Receptinis	LT/1/20/4499/003	Netiekiama	-	-	No	-	-
103116	89217	1089217	dalomoji lizdinė plokštelė	N30x1		Receptinis	LT/1/20/4499/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-11	Perregistruotas
2020-01-24	Registruotas