Itvisma

Medicinal product

(Invented) name

Itvisma

Active substance (s)

Onasemnogenas abeparvovekas

Strength

1,2 × 10(×14) vg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į povoratinklinę ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M09AX09, Onasemnogene abeparvovec

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2026-06-30

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

Flakone (3 ml tirpalo) yra:	3 ml
Onasemnogenas abeparvovekas	1,2 × 10(×14) vg

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
121455	107562	1107562	flakonas	3 ml N1		Receptinis	EU/1/26/2038/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-06-30	Registruotas