Repso

Medicinal product

(Invented) name

Repso

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

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	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
46031	59837	1059837	buteliukas	N30		Receptinis	EU/1/11/674/001	Netiekiama	-	-	No	-	-
46032	59838	1059838	buteliukas	N100		Receptinis	EU/1/11/674/002	Netiekiama	-	-	No	-	-
46033	59839	1059839	lizdinė plokštelė	N28		Receptinis	EU/1/11/674/003	Netiekiama	-	-	No	-	-
46035	59841	1059841	lizdinė plokštelė	N100		Receptinis	EU/1/11/674/004	Netiekiama	-	-	No	-	-
46034	59840	1059840	lizdinė plokštelė	N30		Receptinis	EU/1/11/674/004	Netiekiama	-	-	No	-	-

Stadijos

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