Flixabi

Medicinal product

(Invented) name

Flixabi

Active substance (s)

Infliksimabas

Strength

100 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AB02, Infliximab

Marketing authorisation holder

Samsung Bioepis NL B.V., Nyderlandai

Date of authorisation

2016-05-26

Date of renewal

Documents

Flixabi paciento kortele.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for concentrate for solution for infusion	1 vnt.
Infliksimabas	100 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
65994	80509	1080509	flakonas	N1		Receptinis	EU/1/16/1106/001	Netiekiama	-	-	No	-	-
97621	83715	1083715	flakonas	N2		Receptinis	EU/1/16/1106/002	Netiekiama	-	-	No	-	-
97622	83716	1083716	flakonas	N3		Receptinis	EU/1/16/1106/003	Netiekiama	-	-	No	-	-
97623	83717	1083717	flakonas	N4		Receptinis	EU/1/16/1106/004	Netiekiama	-	-	No	-	-
97624	83718	1083718	flakonas	N5		Receptinis	EU/1/16/1106/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-26	Registruotas