Edoxaban G.L. Pharma

Medicinal product

(Invented) name

Edoxaban G.L. Pharma

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

G.L. Pharma GmbH, Austrija

Date of authorisation

2025-12-11

Date of renewal

Documents

5925-27_pakuotes lapelis_2025-12-11.docx

5925-27_Edoxaban GL_Pharma.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/6114/001/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
119373	105478	1105478	lizdinė plokštelė	N10		Receptinis	LT/1/25/5925/001	Netiekiama	-	-	No	-	-
119374	105479	1105479	lizdinė plokštelė	N28		Receptinis	LT/1/25/5925/002	Netiekiama	-	-	No	-	-
119375	105480	1105480	lizdinė plokštelė	N30		Receptinis	LT/1/25/5925/003	Netiekiama	-	-	No	-	-
119376	105481	1105481	lizdinė plokštelė	N98		Receptinis	LT/1/25/5925/004	Netiekiama	-	-	No	-	-
119377	105482	1105482	lizdinė plokštelė	N100		Receptinis	LT/1/25/5925/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-12-11	Registruotas