Arava

Medicinal product

(Invented) name

Arava

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

Sanofi-Aventis Deutschland GmbH, Vokietija

Date of authorisation

1999-09-02

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

Film-coated tablets	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
1225	4283	1004283	lizdinė plokštelė	N30		Receptinis	EU/1/99/118/001	Netiekiama	-	-	No	-	-
6954	11948	1011948	lizdinė plokštelė	N100		Receptinis	EU/1/99/118/002	Netiekiama	-	-	No	-	-
24903	27535	1027535	buteliukas	N30		Receptinis	EU/1/99/118/003	Netiekiama	-	-	No	-	-
24904	27536	1027536	buteliukas	N100		Receptinis	EU/1/99/118/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1999-09-02	Registruotas