Ultomiris

Medicinal product

(Invented) name

Ultomiris

Active substance (s)

Ravulizumabas

Strength

300 mg/3 ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AJ02, ravulizumab

Marketing authorisation holder

Alexion Europe SAS, Prancūzija

Date of authorisation

2019-07-02

Date of renewal

Documents

Ultomiris mokomoji medziaga pacientams_tevams_globejams.pdf

Ultomiris mokomoji medziaga sveikatos prieziuros specialistams.pdf

Ultomiris paciento kortele.pdf

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

Concentrate for solution for infusion	3 ml
Ravulizumabas	300 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
105401	91501	1091501	flakonas	3 ml N1		Receptinis	EU/1/19/1371/002	Tiekiama	2024-10-30	-	No	-	-

Stadijos

Data	Stadija
2019-07-02	Registruotas