Edoxaban TAD

Medicinal product

(Invented) name

Edoxaban TAD

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

TAD Pharma GmbH, Vokietija

Date of authorisation

2024-09-23

Date of renewal

Documents

5576-78_pakuotes lapelis_2024-09-23.docx

5576_5578 Edoxaban TAD PCS 2025 03 21.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SI/H/0318/001/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
115027	101137	1101137	lizdinė plokštelė	N10		Receptinis	LT/1/24/5576/001	Netiekiama	-	-	No	-	-
115028	101138	1101138	dalomoji lizdinė plokštelė	N10×1		Receptinis	LT/1/24/5576/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-23	Registruotas