Soliris

Medicinal product

(Invented) name

Soliris

Active substance (s)

Ekulizumabas

Strength

300 mg

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)

L04AJ01, Eculizumab

Marketing authorisation holder

Alexion Europe SAS, Prancūzija

Date of authorisation

2007-06-20

Date of renewal

Documents

Soliris mokomoji medziaga sveikatos prieziuros specialistams .pdf

Soliris paciento kortele.pdf

Soliris mokomoji medziaga pacientams_tevams_globejams.pdf

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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	30 ml
Ekulizumabas	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
28283	30813	1030813	flakonas	N1		Receptinis	EU/1/07/393/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-06-20	Registruotas