Macitentan Norameda

Medicinal product

(Invented) name

Macitentan Norameda

Active substance (s)

Macitentanas

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)

C02KX04, Macitentan

Marketing authorisation holder

UAB Norameda, Lietuva

Date of authorisation

2025-03-28

Date of renewal

Documents

5742_Macitentan Norameda.docx

5742_pakuotes lapelis_2025-03-28.docx

Macitentan Norameda paciento kortele.pdf

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0616/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Macitentanas	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
117048	103149	1103149	lizdinė plokštelė	N30		Receptinis	LT/1/25/5742/001	Netiekiama	-	2026-01-31	No	-	-

Stadijos

Data	Stadija
2025-03-28	Registruotas