Leflunomide Zentiva

Medicinal product

(Invented) name

Leflunomide Zentiva

Active substance (s)

Leflunomidas

Strength

100 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	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
39263	52946	1052946	lizdinė plokštelė	N3		Receptinis	EU/1/09/604/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-01-08	Registruotas