Selexipag STADA

Medicinal product

(Invented) name

Selexipag STADA

Active substance (s)

Seleksipagas

Strength

1600 µg

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)

B01AC27, Selexipag

Marketing authorisation holder

STADA Arzneimittel AG, Vokietija

Date of authorisation

2025-11-27

Date of renewal

Documents

5900-5907_Selexipag STADA.docx

5900-07_pakuotes lapelis_2025-11-27.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/6182/008/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Seleksipagas	1600 µg

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
119247	105351	1105351	lizdinė plokštelė	N60		Receptinis	LT/1/25/5907/001	Netiekiama	-	-	No	-	-
119248	105352	1105352	dalomoji lizdinė plokštelė	N60×1		Receptinis	LT/1/25/5907/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-11-27	Registruotas
2025-11-27	Registruotas