STELARA

Medicinal product

(Invented) name

STELARA

Active substance (s)

Ustekinumabas

Strength

130 mg

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)

L04AC05, Ustekinumab

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2009-01-16

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

Concentrate for solution for infusion	26 ml
Ustekinumabas	130 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
67654	82209	1082209	flakonas	26 ml N1		Receptinis	EU/1/08/494/005	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-01-16	Registruotas