Edoxaban G.L. Pharma

Medicinal product

(Invented) name

Edoxaban G.L. Pharma

Active substance (s)

Edoksabanas

Strength

30 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/6114/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Edoksabanas	30 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
119378	105483	1105483	lizdinė plokštelė	N10		Receptinis	LT/1/25/5926/001	Netiekiama	-	-	No	-	-
119379	105484	1105484	lizdinė plokštelė	N28		Receptinis	LT/1/25/5926/002	Netiekiama	-	-	No	-	-
119380	105485	1105485	lizdinė plokštelė	N30		Receptinis	LT/1/25/5926/003	Netiekiama	-	-	No	-	-
119381	105486	1105486	lizdinė plokštelė	N98		Receptinis	LT/1/25/5926/004	Netiekiama	-	-	No	-	-
119382	105487	1105487	lizdinė plokštelė	N100		Receptinis	LT/1/25/5926/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-12-11	Registruotas