Adempas

Medicinal product

(Invented) name

Adempas

Active substance (s)

Riociguatas

Strength

1,5 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)

C02KX05, Riociguat

Marketing authorisation holder

Bayer AG, Vokietija

Date of authorisation

2014-03-27

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

Film-coated tablet	1 vnt.
Riociguatas	1,5 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
58832	73048	1073048	lizdinė plokštelė	N42		Receptinis	EU/1/13/907/007	Tiekiama	-	-	No	-	-
58833	73049	1073049	lizdinė plokštelė	N84		Receptinis	EU/1/13/907/008	Netiekiama	-	-	No	-	-
58834	73050	1073050	lizdinė plokštelė	N90		Receptinis	EU/1/13/907/009	Netiekiama	-	-	No	-	-
60690	74979	1074979	lizdinė plokštelė	N294		Receptinis	EU/1/13/907/018	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-03-27	Registruotas