Inovelon

Medicinal product

(Invented) name

Inovelon

Active substance (s)

Rufinamidas

Strength

40 mg/ml

Pharmaceutical form

geriamoji suspensija

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

2011-11-21

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

Oral suspension	1 ml
Rufinamidas	40 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
50146	64022	1064022	buteliukas	460 ml + 2 švirkštai N1		Receptinis	EU/1/06/378/017	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-11-21	Registruotas