Kevzara

Medicinal product

(Invented) name

Kevzara

Active substance (s)

Sarilumabas

Strength

200 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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

Solution for injection in pre-filled syringe	1.14 ml
Sarilumabas	200 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
68620	83202	1083202	užpildytas švirkštas	N2		Receptinis	EU/1/17/1196/003	Netiekiama	-	-	No	-	-
68621	83203	1083203	užpildytas švirkštas	N6 (3x2)		Receptinis	EU/1/17/1196/004	Netiekiama	-	-	No	-	-
98474	84577	1084577	užpildytas švirkštas	N1		Receptinis	EU/1/17/1196/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-06-23	Registruotas