Otulfi

Medicinal product

(Invented) name

Otulfi

Active substance (s)

Ustekinumabas

Strength

45 mg

Pharmaceutical form

injekcinis tirpalas

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

Flakone yra	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
117701	103805	1103805	flakonas	0.5 ml N1		Receptinis	EU/1/24/1863/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-25	Registruotas