Masipah

Medicinal product

(Invented) name

Masipah

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 Niromed, Lietuva

Date of authorisation

2026-10-02

Date of renewal

Documents

3625_Masipah_PZ.docx

3625_Masipah_PL.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
122513	108623	1108623	lizdinė plokštelė	N14		Receptinis	LT/L/26/3625/001	Netiekiama	-	-	No	-	-
122515	108625	1108625	lizdinė plokštelė	N28		Receptinis	LT/L/26/3625/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-10-02	Registruotas