Remicade

Medicinal product

(Invented) name

Remicade

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

Janssen Biologics B.V., Nyderlandai

Date of authorisation

2000-07-04

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

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
1362	7116	1007116	flakonas	N1		Receptinis	EU/1/99/116/001	Tiekiama	-	-	No	-	-
28115	30651	1030651	flakonas	N2		Receptinis	EU/1/99/116/002	Netiekiama	-	-	No	-	-
28116	30652	1030652	flakonas	N3		Receptinis	EU/1/99/116/003	Netiekiama	-	-	No	-	-
34340	36689	1036689	flakonas	N4		Receptinis	EU/1/99/116/004	Netiekiama	-	-	No	-	-
34341	36690	1036690	flakonas	N5		Receptinis	EU/1/99/116/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2000-07-04	Registruotas