Leflunomide Zentiva

Medicinal product

(Invented) name

Leflunomide Zentiva

Active substance (s)

Leflunomidas

Strength

20 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	20 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
39258	52941	1052941	buteliukas	N30		Receptinis	EU/1/09/604/005	Netiekiama	-	-	No	-	-
39259	52942	1052942	buteliukas	N50		Receptinis	EU/1/09/604/006	Netiekiama	-	-	No	-	-
39260	52943	1052943	buteliukas	N100		Receptinis	EU/1/09/604/007	Netiekiama	-	-	No	-	-
39261	52944	1052944	lizdinė plokštelė	N30		Receptinis	EU/1/09/604/008	Netiekiama	-	-	No	-	-
39262	52945	1052945	lizdinė plokštelė	N100		Receptinis	EU/1/09/604/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-01-08	Registruotas