PALYNZIQ SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PEGVALIASE

Tersedia dari:

BIOMARIN INTERNATIONAL LIMITED

Kode ATC:

A16AB19

INN (Nama Internasional):

PEGVALIASE

Dosis:

2.5MG

Bentuk farmasi:

SOLUTION

Komposisi:

PEGVALIASE 2.5MG

Rute administrasi :

SUBCUTANEOUS

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Ringkasan produk:

Active ingredient group (AIG) number: 0163521002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2022-03-30

Karakteristik produk

PALYNZIQ® (pegvaliase injection)
Page 1 of 38
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PALYNZIQ
®
pegvaliase injection
Solution
2.5 mg/0.5 mL (5 mg/mL), 10 mg/0.5 mL (20 mg/mL), 20 mg/1.0 mL (20
mg/mL)
Subcutaneous injection
Recombinant phenylalanine ammonia lyase (rAvPAL) is manufactured in
_Escherichia coli_ bacteria
transformed with a plasmid containing the phenylalanine ammonia lyase
(PAL) gene derived from
_Anabaena variabilis_
Alimentary Tract and Metabolism Products
BioMarin International Limited
Shanbally, Ringaskiddy
County Cork, Ireland
Distributor:
BioMarin Pharmaceutical (Canada) Inc.
Toronto, ON
Canada M5H 3C2
Date of Initial Authorization:
MAR 30, 2022
Date of Revision:
APR 4, 2023
Submission Control Number: 269980
PALYNZIQ® (pegvaliase injection)
Page 2 of 38
_ _
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage A