STELARA

Medicinal product

(Invented) name

STELARA

Active substance (s)

Ustekinumabas

Strength

45 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

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

Solution for injection in pre-filled pen	0.5 ml
Ustekinumabas	45 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
111249	97362	1097362	užpildytas švirkštiklis	0,5 ml N1		Receptinis	EU/1/08/494/006	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-01-16	Registruotas