SYLVANT

Medicinal product

(Invented) name

SYLVANT

Active substance (s)

Siltuksimabas

Strength

400 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)

L04AC11, Siltuximab

Marketing authorisation holder

Recordati Netherlands B.V., Nyderlandai

Date of authorisation

2014-05-22

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

Powder for concentrate for solution	1 vnt.
Siltuksimabas	400 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
59244	73469	1073469	flakonas	N1		Receptinis	EU/1/14/928/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-05-22	Registruotas