Teriflunomide Zentiva

Medicinal product

(Invented) name

Teriflunomide Zentiva

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

Zentiva k.s., Čekija

Date of authorisation

2023-03-07

Date of renewal

Documents

Teriflunomide Zentiva mokomoji medziaga sveikatos prieziuros specialistams.pdf

5130 Pakuotės lapelis 2024 12 02.docx

5130 Teriflunomide Zentiva PCS PL 2024 12 02.docx

Teriflunomide Zentiva paciento kortele.pdf

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0469/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

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
110507	96617	1096617	lizdinė plokštelė	N28		Receptinis	LT/1/23/5130/001	Netiekiama	-	-	No	-	-
110509	96619	1096619	lizdinė plokštelė	N84		Receptinis	LT/1/23/5130/002	Netiekiama	-	-	No	-	-
112535	98655	1098655	lizdinė plokštelė	N14		Receptinis	LT/1/23/5130/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-07	Registruotas