Adempas

Medicinal product

(Invented) name

Adempas

Active substance (s)

Riociguatas

Strength

0,5 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	0,5 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
58826	73042	1073042	lizdinė plokštelė	N42		Receptinis	EU/1/13/907/001	Tiekiama	-	-	No	-	-
58827	73043	1073043	lizdinė plokštelė	N84		Receptinis	EU/1/13/907/002	Netiekiama	-	-	No	-	-
58828	73044	1073044	lizdinė plokštelė	N90		Receptinis	EU/1/13/907/003	Netiekiama	-	-	No	-	-
60688	74977	1074977	lizdinė plokštelė	N294		Receptinis	EU/1/13/907/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-03-27	Registruotas