Edoxaban Accord [Edoxaban Tiefenbacher]

Medicinal product

(Invented) name

Edoxaban Accord [Edoxaban Tiefenbacher]

Active substance (s)

Edoksabanas

Strength

60 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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2025-06-17

Date of renewal

Documents

5804_5806 Edoxaban Accord RPP 2025 10 30.docx

5804_5806 Pakuotės lapelis 2025 10 30.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/1331/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Edoksabanas	60 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
117772	103876	1103876	lizdinė plokštelė	N28		Receptinis	LT/1/25/5806/001	Netiekiama	-	-	No	-	-
117773	103877	1103877	lizdinė plokštelė	N30		Receptinis	LT/1/25/5806/002	Netiekiama	-	-	No	-	-
117774	103878	1103878	lizdinė plokštelė	N60		Receptinis	LT/1/25/5806/003	Netiekiama	-	-	No	-	-
117775	103879	1103879	lizdinė plokštelė	N98		Receptinis	LT/1/25/5806/004	Netiekiama	-	-	No	-	-
117776	103880	1103880	lizdinė plokštelė	N100		Receptinis	LT/1/25/5806/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-17	Registruotas