Lixiana

Medicinal product

(Invented) name

Lixiana

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

Daiichi Sankyo Europe GmbH, Vokietija

Date of authorisation

2015-06-19

Date of renewal

Documents

Lixiana mokomoji medžiaga mokomoji medziaga sveikatos prieziuros specialistams.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	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
62501	76911	1076911	lizdinė plokštelė	N10		Receptinis	EU/1/15/993/001	Netiekiama	-	-	No	-	-
62502	76912	1076912	dalomoji lizdinė plokštelė	N10x1		Receptinis	EU/1/15/993/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-06-19	Registruotas