SANDOZ PAZOPANIB TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE)

Tilgjengelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

L01EX03

INN (International Name):

PAZOPANIB

Dosering :

200MG

Legemiddelform:

TABLET

Sammensetning:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE) 200MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0152743001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2021-10-15

Preparatomtale

_Sandoz Pazopanib (pazopanib hydrochloride) Product Monograph _
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR SANDOZ PAZOPANIB
Pazopanib tablets
Tablets, 200 mg pazopanib (as pazopanib hydrochloride), oral
Antineoplastic Agent
Sandoz Canada Inc.
110, De Lauzon
Boucherville, Quebec
J4B 1E6
www.sandoz.ca
Date of Initial Authorization:
October 15, 2021
Date of Revision:
June 29, 2022
Submission Control Number: 261636
®
Registered trademark used under license
_ _
_Sandoz Pazopanib (pazopanib hydrochloride) Product Monograph _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Cardiovascular
06/2022
7 WARNINGS AND PRECAUTIONS, Combinations with other systemic
anti-cancer therapies
06/2022
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
06/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
6
4.1
Dosing Considerations
..........................................