Ultomiris

Medicinal product

(Invented) name

Ultomiris

Active substance (s)

Ravulizumabas

Strength

245 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)

L04AJ02, ravulizumab

Marketing authorisation holder

Alexion Europe SAS, Prancūzija

Date of authorisation

2019-07-02

Date of renewal

Documents

Ultomiris paciento kortele.pdf

Ultomiris mokomoji medziaga pacientams_tevams_globejams.pdf

Ultomiris mokomoji medziaga sveikatos prieziuros specialistams.pdf

Search in EMA Europe

Stage

Išregistruotas

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	3.5 ml
Ravulizumabas	245 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
111101	97212	1097212	užtaisas	3,5 ml N1 (ir injektorius)		Receptinis	EU/1/19/1371/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-04	Išregistruotas
2019-07-02	Registruotas