Rivaroxaban Accord

Medicinal product

(Invented) name

Rivaroxaban Accord

Active substance (s)

Rivaroksabanas+Rivaroksabanas

Strength

15 mg + 20 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)

B01AF01, Rivaroxaban

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2020-11-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet (15 mg)	1 vnt.
Rivaroksabanas	15 mg
Film-coated tablet (20 mg)	1 vnt.
Rivaroksabanas	20 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
105288	91390	1091390	lizdinė plokštelė	N49 (N42x15 mg + N7x20 mg)	pakuotė gydymui pradėti	Receptinis	EU/1/20/1488/039	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-11-16	Registruotas