SANDOZ PAZOPANIB TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE)

Dostupné z:

SANDOZ CANADA INCORPORATED

ATC kód:

L01EX03

INN (Medzinárodný Name):

PAZOPANIB

Dávkovanie:

200MG

Forma lieku:

TABLET

Zloženie:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE) 200MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2021-10-15

Súhrn charakteristických

_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
..........................................