Uptravi

Medicinal product

(Invented) name

Uptravi

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

Janssen-Cilag International N.V., Belgija

Date of authorisation

2016-05-12

Date of renewal

Documents

Uptravi mokomoji medziaga sveikatos prieziuros specialistams.pdf

Uptravi mokomoji medziaga pacientams.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	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
65879	80391	1080391	lizdinė plokštelė	N60		Receptinis	EU/1/15/1083/010	Netiekiama	2024-01-02	2026-07-01	Yes	2025-01-01	2025-12-31

Stadijos

Data	Stadija
2016-05-12	Registruotas