Leflunomide Zentiva

Medicinal product

(Invented) name

Leflunomide Zentiva

Active substance (s)

Leflunomidas

Strength

10 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)

L04AK01, Leflunomide

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2010-01-08

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Leflunomidas	10 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
39254	52937	1052937	buteliukas	N30		Receptinis	EU/1/09/604/001	Netiekiama	-	-	No	-	-
39255	52938	1052938	buteliukas	N100		Receptinis	EU/1/09/604/002	Netiekiama	-	-	No	-	-
39256	52939	1052939	lizdinė plokštelė	N30		Receptinis	EU/1/09/604/003	Netiekiama	-	-	No	-	-
39257	52940	1052940	lizdinė plokštelė	N100		Receptinis	EU/1/09/604/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-01-08	Registruotas