Edoxaban Zentiva

Medicinal product

(Invented) name

Edoxaban Zentiva

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

Zentiva k.s., Čekija

Date of authorisation

2025-03-10

Date of renewal

Documents

Edoxaban Zentiva paciento atmintine.pdf

Edoxaban Zentiva mokomoji medziaga sveikatos prieziuros specialistams.pdf

5726_5727_5728_Edoxaban Zentiva.docx

5726-5728_pakuotes lapelis_2025-03-10.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/1290/001/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
116877	102981	1102981	lizdinė plokštelė	N10		Receptinis	LT/1/25/5726/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-10	Registruotas