Inovelon

Medicinal product

(Invented) name

Inovelon

Active substance (s)

Rufinamidas

Strength

100 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)

N03AF03, Rufinamide

Marketing authorisation holder

Eisai GmbH, Vokietija

Date of authorisation

2007-01-16

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.
Rufinamidas	100 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
25986	28578	1028578	lizdinė plokštelė	N10		Receptinis	EU/1/06/378/001	Netiekiama	-	-	No	-	-
25987	28579	1028579	lizdinė plokštelė	N30		Receptinis	EU/1/06/378/002	Netiekiama	-	-	No	-	-
25988	28580	1028580	lizdinė plokštelė	N50		Receptinis	EU/1/06/378/003	Netiekiama	-	-	No	-	-
25989	28581	1028581	lizdinė plokštelė	N100		Receptinis	EU/1/06/378/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-01-16	Registruotas