Arava

Medicinal product

(Invented) name

Arava

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

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	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
1226	4284	1004284	lizdinė plokštelė	N30		Receptinis	EU/1/99/118/005	Netiekiama	-	-	No	-	-
6955	11949	1011949	lizdinė plokštelė	N100		Receptinis	EU/1/99/118/006	Netiekiama	-	-	No	-	-
1227	7030	1007030	buteliukas	N30		Receptinis	EU/1/99/118/007	Tiekiama	-	-	No	-	-
24905	27537	1027537	buteliukas	N100		Receptinis	EU/1/99/118/008	Netiekiama	-	-	No	-	-
60835	75125	1075125	buteliukas	N50		Receptinis	EU/1/99/118/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1999-09-02	Registruotas