LUXTURNA SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

VORETIGENE NEPARVOVEC

Pieejams no:

NOVARTIS PHARMACEUTICALS CANADA INC

ATĶ kods:

S01XA27

SNN (starptautisko nepatentēto nosaukumu):

VORETIGENE NEPARVOVEC

Deva:

5000000000000VG

Zāļu forma:

SOLUTION

Kompozīcija:

VORETIGENE NEPARVOVEC 5000000000000VG

Ievadīšanas:

SUBRETINAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Ārstniecības joma:

CELLULAR AND GENE THERAPY

Produktu pārskats:

Active ingredient group (AIG) number: 0162520001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2020-10-13

Produkta apraksts

_ _
_LUXTURNA_
_®_
_ (voretigene neparvovec) _
_Page 1 of 30_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LUXTURNA
®
voretigene neparvovec
5 x 10
12
vector genomes/mL concentrate for solution for subretinal injection
Recombinant adeno-associated virus 2 vector-based gene therapy
ATC S01XA27
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
www.novartis.ca
Date of Initial Authorization:
Oct 13, 2020
Date of Revision:
April 20, 2022
Submission Control No: 259137
LUXTURNA is a registered trademark of Spark Therapeutics Inc., used
under license by Novartis
Pharmaceuticals Canada Inc.
_ _
_LUXTURNA_
_®_
_ (voretigene neparvovec) _
_Page 2 of 30_
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES ................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ....................................................... 4
1
INDICATIONS ...........................................................................................................
4
1.1
Pediatrics
............................................................................................................
4
1.2
Geriatrics
............................................................................................................
4
2
CONTRAINDICATIONS ...........................................................................................
4
4
DOSAGE AND ADMINISTRATION .........................................................................
4
4.1
Dosing Considerations
........................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
..................................................... 4
4.3
Reconstitution
.....................................................................................................
6
4.4
Administration