Safinamide Teva

Medicinal product

(Invented) name

Safinamide Teva

Active substance (s)

Safinamidas

Strength

100 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)

N04BD03, Safinamide

Marketing authorisation holder

Teva GmbH, Vokietija

Date of authorisation

2026-01-16

Date of renewal

Documents

5948_49_Safinamide Teva.docx

5948_49_pakuotes lapelis_2026-01-16.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/2678/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Safinamidas	100 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
119707	105813	1105813	lizdinė plokštelė	N14		Receptinis	LT/1/26/5949/001	Netiekiama	-	-	No	-	-
119708	105814	1105814	lizdinė plokštelė	N30		Receptinis	LT/1/26/5949/002	Netiekiama	-	-	No	-	-
119709	105815	1105815	lizdinė plokštelė	N100		Receptinis	LT/1/26/5949/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-01-16	Registruotas