Inflectra

Medicinal product

(Invented) name

Inflectra

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

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2013-09-10

Date of renewal

Documents

Inflectra 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
57085	71198	1071198	flakonas	N1		Receptinis	EU/1/13/854/001	Netiekiama	-	-	No	-	-
57086	71199	1071199	flakonas	N2		Receptinis	EU/1/13/854/002	Netiekiama	-	-	No	-	-
57087	71200	1071200	flakonas	N3		Receptinis	EU/1/13/854/003	Netiekiama	-	-	No	-	-
57088	71201	1071201	flakonas	N4		Receptinis	EU/1/13/854/004	Netiekiama	-	-	No	-	-
57089	71202	1071202	flakonas	N5		Receptinis	EU/1/13/854/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-09-10	Registruotas