Macitentan Olpha

Medicinal product

(Invented) name

Macitentan Olpha

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

Olpha AS, Latvija

Date of authorisation

2025-11-27

Date of renewal

Documents

5899_Macitentan Olpha.docx

5899_pakuotes lapelis_2025-11-27.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/2558/001/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
119205	105309	1105309	lizdinė plokštelė	N15		Receptinis	LT/1/25/5899/001	Netiekiama	-	-	No	-	-
119206	105310	1105310	lizdinė plokštelė	N30		Receptinis	LT/1/25/5899/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-11-27	Registruotas