Inovelon

Medicinal product

(Invented) name

Inovelon

Active substance (s)

Rufinamidas

Strength

200 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	200 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
25990	28582	1028582	lizdinė plokštelė	N10		Receptinis	EU/1/06/378/006	Netiekiama	-	-	No	-	-
25991	28583	1028583	lizdinė plokštelė	N30		Receptinis	EU/1/06/378/007	Netiekiama	-	-	No	-	-
25992	28584	1028584	lizdinė plokštelė	N50		Receptinis	EU/1/06/378/008	Tiekiama	-	-	No	-	-
25993	28585	1028585	lizdinė plokštelė	N60		Receptinis	EU/1/06/378/009	Netiekiama	-	-	No	-	-
25994	28586	1028586	lizdinė plokštelė	N100		Receptinis	EU/1/06/378/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-01-16	Registruotas