SANDOZ PAZOPANIB TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE)

Commercializzato da:

SANDOZ CANADA INCORPORATED

Codice ATC:

L01EX03

INN (Nome Internazionale):

PAZOPANIB

Dosaggio:

200MG

Forma farmaceutica:

TABLET

Composizione:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE) 200MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2021-10-15

Scheda tecnica

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