Repso

Medicinal product

(Invented) name

Repso

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

Teva B.V., Nyderlandai

Date of authorisation

2011-03-14

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

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
46036	59842	1059842	buteliukas	N30		Receptinis	EU/1/11/674/006	Netiekiama	-	-	No	-	-
46037	59843	1059843	buteliukas	N100		Receptinis	EU/1/11/674/007	Netiekiama	-	-	No	-	-
46038	59844	1059844	lizdinė plokštelė	N28		Receptinis	EU/1/11/674/008	Netiekiama	-	-	No	-	-
46039	59845	1059845	lizdinė plokštelė	N28		Receptinis	EU/1/11/674/009	Netiekiama	-	-	No	-	-
46040	59846	1059846	lizdinė plokštelė	N100		Receptinis	EU/1/11/674/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-07-21	Išregistruotas
2011-03-14	Registruotas