Edoxaban G.L. Pharma

Medicinal product

(Invented) name

Edoxaban G.L. Pharma

Active substance (s)

Edoksabanas

Strength

60 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/6114/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Edoksabanas	60 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
119383	105488	1105488	lizdinė plokštelė	N10		Receptinis	LT/1/25/5927/001	Netiekiama	-	-	No	-	-
119384	105489	1105489	lizdinė plokštelė	N28		Receptinis	LT/1/25/5927/002	Netiekiama	-	-	No	-	-
119385	105490	1105490	lizdinė plokštelė	N30		Receptinis	LT/1/25/5927/003	Netiekiama	-	-	No	-	-
119386	105491	1105491	lizdinė plokštelė	N98		Receptinis	LT/1/25/5927/004	Netiekiama	-	-	No	-	-
119387	105492	1105492	lizdinė plokštelė	N100		Receptinis	LT/1/25/5927/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-12-11	Registruotas