Keppra

Medicinal product

(Invented) name

Keppra

Active substance (s)

Levetiracetamas

Strength

100 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N03AX14, Levetiracetam

Marketing authorisation holder

UCB Pharma S.A., Belgija

Date of authorisation

2003-03-03

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 solution	1 ml
Levetiracetamas	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
26422	29000	1029000	buteliukas	300 ml ir geriamasis švirkštas (10 ml) N1		Receptinis	EU/1/00/146/027	Netiekiama	-	-	No	-	-
37224	50844	1050844	buteliukas	150 ml ir geriamasis švirkštas (3 ml) N1		Receptinis	EU/1/00/146/031	Netiekiama	-	-	No	-	-
37225	50845	1050845	buteliukas	150 ml ir geriamasis švirkštas (1 ml) N1		Receptinis	EU/1/00/146/032	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2003-03-03	Registruotas