Delianda

Medicinal product

(Invented) name

Delianda

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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2024-09-17

Date of renewal

Documents

5571-73_pakuotes lapelis_2024-09-17.docx

Delianda mokomoji medziaga sveikatos prieziuros specialistams.pdf

Delianda paciento kortele.pdf

5571_5573 Delianda PCS 2025 03 21.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SI/H/0293/001/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
114945	101052	1101052	lizdinė plokštelė	N10		Receptinis	LT/1/24/5571/001	Netiekiama	-	-	No	-	-
114946	101053	1101053	dalomoji lizdinė plokštelė	N10×1		Receptinis	LT/1/24/5571/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-17	Registruotas