Sarclisa

Medicinal product

(Invented) name

Sarclisa

Active substance (s)

Isatuksimabas

Strength

140 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FC02, Isatuximab

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2020-05-30

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 injekcinio tirpalo yra:	1 ml
Isatuksimabas	140 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
121332	107440	1107440	flakonas	10 ml N1		Receptinis	EU/1/20/1435/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-05-30	Registruotas