Roteas

Medicinal product

(Invented) name

Roteas

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

Berlin-Chemie AG, Vokietija

Date of authorisation

2017-04-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10c

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
68213	82780	1082780	lizdinė plokštelė	N10		Receptinis	EU/1/16/1152/001	Netiekiama	-	-	No	-	-
68214	82781	1082781	dalomoji lizdinė plokštelė	N10x1		Receptinis	EU/1/16/1152/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-04-20	Registruotas