Edoxaban Accord [Edoxaban Tiefenbacher]

Medicinal product

(Invented) name

Edoxaban Accord [Edoxaban Tiefenbacher]

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2025-06-17

Date of renewal

Documents

5804_5806 Pakuotės lapelis 2025 10 30.docx

5804_5806 Edoxaban Accord RPP 2025 10 30.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/1331/001/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
117766	103870	1103870	lizdinė plokštelė	N10		Receptinis	LT/1/25/5804/001	Netiekiama	-	-	No	-	-
117767	103871	1103871	lizdinė plokštelė	N30		Receptinis	LT/1/25/5804/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-17	Registruotas