Edoxaban Olpha

Medicinal product

(Invented) name

Edoxaban Olpha

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

Olpha AS, Latvija

Date of authorisation

2025-03-10

Date of renewal

Documents

5723-25_pakuotes lapelis_2025-03-10.docx

Edoxaban Olpha mokomoji medziaga sveikatos prieziuros specialistams.pdf

5723-5724-5725_Edoxaban_Olpha.docx

Edoxaban Olpha mokomoji medziaga pacientui.pdf

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HR/H/0257/001/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
116861	102965	1102965	lizdinė plokštelė	N10		Receptinis	LT/1/25/5723/001	Netiekiama	-	-	No	-	-
116862	102966	1102966	lizdinė plokštelė	N14		Receptinis	LT/1/25/5723/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-10	Registruotas