Zilbrysq

Medicinal product

(Invented) name

Zilbrysq

Active substance (s)

Zilukoplanas

Strength

16,6 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)

L04AJ06, zilucoplan

Marketing authorisation holder

UCB Pharma S.A., Belgija

Date of authorisation

2023-12-01

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 syringe	0.416 ml
Zilukoplanas	16,6 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
112163	98278	1098278	užpildytas švirkštas	N7		Receptinis	EU/1/23/1764/001	Netiekiama	-	-	No	-	-
112164	98279	1098279	užpildytas švirkštas	N28 (4×7)		Receptinis	EU/1/23/1764/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-01	Registruotas