Rystiggo

Medicinal product

(Invented) name

Rystiggo

Active substance (s)

Rozanoliksizumabas

Strength

140 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AG16, rozanolixizumab

Marketing authorisation holder

UCB Pharma S.A., Belgija

Date of authorisation

2024-01-05

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

1 ml tirpalo yra:	1 ml
Rozanoliksizumabas	140 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
112507	98627	1098627	flakonas	2 ml N1		Receptinis	EU/1/23/1780/001	Netiekiama	-	-	No	-	-
114868	100973	1100973	flakonas	3 ml N1		Receptinis	EU/1/23/1780/002	Netiekiama	-	-	No	-	-
114869	100974	1100974	flakonas	4 ml N1		Receptinis	EU/1/23/1780/003	Netiekiama	-	-	No	-	-
114870	100975	1100975	flakonas	6 ml N1		Receptinis	EU/1/23/1780/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-05	Registruotas