Beqvez [DURVEQTIX]

Medicinal product

(Invented) name

Beqvez [DURVEQTIX]

Active substance (s)

Fidanakogenas elaparvovekas

Strength

0,79–1,21×10(×13) vg/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)

B02BD17, fidanacogene elaparvovec

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2024-07-24

Date of renewal

Documents

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

1 ml tirpalo yra:	1 ml
Fidanakogenas elaparvovekas	0,79–1,21×10(×13) vg/ml

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
114657	100764	1100764	flakonas	N1		Receptinis	EU/1/24/1838/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-05-15	Išregistruotas
2024-07-24	Registruotas