Edoxaban STADA Arzneimittel

Medicinal product

(Invented) name

Edoxaban STADA Arzneimittel

Active substance (s)

Edoksabanas

Strength

15 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)

B01AF03, Edoxaban

Marketing authorisation holder

STADA Arzneimittel AG, Vokietija

Date of authorisation

2026-09-28

Date of renewal

Documents

6157-59_Edoxaban STADA Arzneimittel.docx

6157-9_pakuotes lapelis_2026-09-28.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0702/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Edoksabanas	15 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
122381	108494	1108494	lizdinė plokštelė	N10		Receptinis	LT/1/26/6157/001	Netiekiama	-	-	No	-	-
122382	108495	1108495	dalomoji lizdinė plokštelė	N10×1		Receptinis	LT/1/26/6157/002	Netiekiama	-	-	No	-	-
122383	108496	1108496	buteliukas	N100		Receptinis	LT/1/26/6157/003	Netiekiama	-	-	No	-	-
122384	108497	1108497	buteliukas	N500		Receptinis	LT/1/26/6157/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-09-28	Registruotas