Kevzara

Medicinal product

(Invented) name

Kevzara

Active substance (s)

Sarilumabas

Strength

175 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AC14, Sarilumab

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2017-06-23

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

1 ml tirpalo yra:	1.54 ml
Sarilumabas	175 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
116316	102418	1102418	flakonas	N2		Receptinis	EU/1/17/1196/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-06-23	Registruotas