BEKEMV

Medicinal product

(Invented) name

BEKEMV

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

Amgen Technology (Ireland) UC, Airija

Date of authorisation

2023-04-19

Date of renewal

Documents

BEKEMV mokomoji medziaga sveikatos prieziuros specialistams.pdf

BEKEMV vakcinacijos sertifikatas.pdf

BEKEMV mokomoji medziaga pacientams.pdf

BEKEMV paciento kortele.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

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
110889	97000	1097000	flakonas	N1		Receptinis	EU/1/23/1727/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-19	Registruotas