Evkeeza

Medicinal product

(Invented) name

Evkeeza

Active substance (s)

Evinakumabas

Strength

150 mg/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)

C10AX17, evinacumab

Marketing authorisation holder

Ultragenyx Germany GmbH, Vokietija

Date of authorisation

2021-06-17

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

Concentrate for solution for infusion	1 ml
Evinakumabas	150 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
106746	92848	1092848	flakonas	2,3 ml N1		Receptinis	EU/1/21/1551/001	Netiekiama	-	-	No	-	-
106747	92849	1092849	flakonas	8 ml N1		Receptinis	EU/1/21/1551/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-06-17	Registruotas