Otulfi

Medicinal product

(Invented) name

Otulfi

Active substance (s)

Ustekinumabas

Strength

90 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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

Fresenius Kabi Deutschland GmbH, Vokietija

Date of authorisation

2024-09-25

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Užpildytame švirkšte (1 ml tirpalo) yra:	1 ml
Ustekinumabas	90 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
115198	101307	1101307	užpildytas švirkštas	1 ml N1		Receptinis	EU/1/24/1863/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-25	Registruotas