Luxturna

Medicinal product

(Invented) name

Luxturna

Active substance (s)

Voretigenas neparvovekas

Strength

5x10(12) vektoriaus genomų/ml

Pharmaceutical form

koncentratas ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti po tinklaine

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01XA27, voretigene neparvovec

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2018-11-22

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 and solvent for solution for injection	1 ml
Voretigenas neparvovekas	5x10(12) vektoriaus genomų/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
100657	86767	1086767	flakonas	N1 ir 2 flakonai tirpiklio		Receptinis	EU/1/18/1331/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-11-22	Registruotas