Skyrizi

Medicinal product

(Invented) name

Skyrizi

Active substance (s)

Risankizumabas

Strength

360 mg

Pharmaceutical form

injekcinis tirpalas užtaise

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AC18, risankizumab

Marketing authorisation holder

AbbVie Deutschland GmbH & Co. KG , Vokietija

Date of authorisation

2019-04-26

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 cartridge	2.4 ml
Risankizumabas	360 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
109905	96012	1096012	užtaisas	N1 + ant kūno tvirtinamas injektorius		Receptinis	EU/1/19/1361/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-04-26	Registruotas