Teriflunomide Accord

Medicinal product

(Invented) name

Teriflunomide Accord

Active substance (s)

Teriflunomidas

Strength

14 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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2022-11-09

Date of renewal

Documents

Teriflunomide Accord mokomoji medziaga sveikatos prieziuros specialistams.pdf

Teriflunomide Accord paciento kortele.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Teriflunomidas	14 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
109828	95935	1095935	lizdinė plokštelė	N28		Receptinis	EU/1/22/1693/001	Netiekiama	-	-	No	-	-
109829	95936	1095936	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/22/1693/002	Netiekiama	-	-	No	-	-
109830	95937	1095937	lizdinė plokštelė	N84		Receptinis	EU/1/22/1693/003	Netiekiama	-	-	No	-	-
109831	95938	1095938	dalomoji lizdinė plokštelė	N84×1		Receptinis	EU/1/22/1693/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-11-09	Registruotas