Remsima

Medicinal product

(Invented) name

Remsima

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

Celltrion Healthcare Hungary Kft., Vengrija

Date of authorisation

2013-09-10

Date of renewal

Documents

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
57084	71197	1071197	flakonas	N1		Receptinis	EU/1/13/853/001	Tiekiama	-	-	No	-	-
61787	76143	1076143	flakonas	N2		Receptinis	EU/1/13/853/002	Netiekiama	-	-	No	-	-
61788	76144	1076144	flakonas	N3		Receptinis	EU/1/13/853/003	Netiekiama	-	-	No	-	-
61789	76145	1076145	flakonas	N4		Receptinis	EU/1/13/853/004	Netiekiama	-	-	No	-	-
61790	76146	1076146	flakonas	N5		Receptinis	EU/1/13/853/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-09-10	Registruotas