TIFAY

Medicinal product

(Invented) name

TIFAY

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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2022-11-08

Date of renewal

Documents

5060 Pakuotės lapelis 2024 11 01.docx

TIFAY mokomoji medziaga sveikatos prieziuros specialistams.pdf

5060 TIFAY PCS PL 2024 11 01.docx

TIFAY paciento kortele.pdf

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0474/001/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
109713	95820	1095820	lizdinė plokštelė	N28		Receptinis	LT/1/22/5060/001	Tiekiama	-	-	No	-	-	Download
109714	95821	1095821	lizdinė plokštelė	N84		Receptinis	LT/1/22/5060/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-11-08	Registruotas