AUBAGIO

Medicinal product

(Invented) name

AUBAGIO

Active substance (s)

Teriflunomidas

Strength

7 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)

L04AK02, Teriflunomide

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2013-08-26

Date of renewal

Documents

Aubagio mokomoji medziaga sveikatos prieziuros specialistams.pdf

Aubagio paciento kortele.pdf

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 tablet	1 vnt.
Teriflunomidas	7 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
106733	92835	1092835	lizdinė plokštelė	N28		Receptinis	EU/1/13/838/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-08-26	Registruotas