SARCLISA

Medicinal product

(Invented) name

SARCLISA

Active substance (s)

Isatuksimabas

Strength

20 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

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

SARCLISA mokomoji medziaga sveikatos prieziuros specialistams ir kraujo bankams.pdf

SARCLISA paciento kortele.pdf

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

Concentrate for solution for infusion	1 ml
Isatuksimabas	20 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
104243	90347	1090347	flakonas	5 ml N1		Receptinis	EU/1/20/1435/001	Netiekiama	-	-	No	-	-
104244	90348	1090348	flakonas	5 ml N3		Receptinis	EU/1/20/1435/002	Netiekiama	-	-	No	-	-
104245	90349	1090349	flakonas	25 ml N1		Receptinis	EU/1/20/1435/003	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-05-30	Registruotas