Opsumit

Medicinal product

(Invented) name

Opsumit

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

Janssen-Cilag International N.V., Belgija

Date of authorisation

2013-12-20

Date of renewal

Documents

Opsumit paciento kortele.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.
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
58382	72544	1072544	lizdinė plokštelė	N15		Receptinis	EU/1/13/893/001	Netiekiama	-	-	No	-	-
58383	72545	1072545	lizdinė plokštelė	N30		Receptinis	EU/1/13/893/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-12-20	Registruotas