Rivaroxaban G.L. Pharma

Medicinal product

(Invented) name

Rivaroxaban G.L. Pharma

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

G.L. Pharma GmbH, Austrija

Date of authorisation

2020-09-30

Date of renewal

Documents

4618_4619_4620_1_12 Rivaroxaban G_L Pharma II PL 210303.docx

4619_4620_1_12 Pakuotės lapelis 210303.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0406/003-004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje (15 mg) yra:	1 vnt.
Rivaroksabanas	15 mg
Tabletėje (20 mg) yra:	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
105123	91225	1091225	lizdinė plokštelė	N49 (N42 (15 mg) + N7 (20 mg))	pakuotė gydymui pradėti	Receptinis	LT/1/20/4621/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-01	Išregistruotas
2020-09-30	Registruotas