Tenamid

Medicinal product

(Invented) name

Tenamid

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

LV System Service SIA, Latvija

Date of authorisation

2024-06-03

Date of renewal

Documents

LT_0207_DC_PAR_SD+Summ+LT apžvalga.pdf

5459 Pakuotės lapelis 2024 10 01.docx

5459 Tenamid PCS PL 2024 10 01.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0207/001/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
113815	99932	1099932	lizdinė plokštelė	N14		Receptinis	LT/1/24/5459/001	Netiekiama	-	-	No	-	-
113816	99933	1099933	lizdinė plokštelė	N28		Receptinis	LT/1/24/5459/002	Netiekiama	-	-	No	-	-
113817	99934	1099934	lizdinė plokštelė	N84		Receptinis	LT/1/24/5459/003	Netiekiama	-	-	No	-	-
113818	99935	1099935	lizdinė plokštelė	N98		Receptinis	LT/1/24/5459/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-06-03	Registruotas