Opsumit

Medicinal product

(Invented) name

Opsumit

Active substance (s)

Macitentanas

Strength

2,5 mg

Pharmaceutical form

disperguojamosios 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

Janssen-Cilag International N.V., Belgija

Date of authorisation

2013-12-20

Date of renewal

Documents

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

Tabletėje yra:	1 vnt.
Macitentanas	2,5 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
115826	101929	1101929	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/13/893/004	Nepradėtas tiekti	-	-	No	-	-

Stadijos

Data	Stadija
2013-12-20	Registruotas