SANDOZ PAZOPANIB TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

L01EX03

INN (International Name):

PAZOPANIB

Dosage:

200MG

Pharmaceutical form:

TABLET

Composition:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE) 200MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2021-10-15

Summary of Product characteristics

_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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
6
4.1
Dosing Considerations
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