Hemgenix

Medicinal product

(Invented) name

Hemgenix

Active substance (s)

Etranakogenas dezaparvovekas

Strength

1 x 10(x13) gk/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)

B02BD16, etranacogene dezaparvovec

Marketing authorisation holder

CSL Behring GmbH, Vokietija

Date of authorisation

2023-02-20

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
Etranakogenas dezaparvovekas	1 x 10(x13) gk

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
110470	96580	1096580	flakonas	10 ml N1 (x flakonų, skirtų paciento dozei, skaičius)		Receptinis	EU/1/22/1715/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-02-20	Registruotas