PMS-PAZOPANIB TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE)

Disponibil de la:

PHARMASCIENCE INC

Codul ATC:

L01EX03

INN (nume internaţional):

PAZOPANIB

Dozare:

200MG

Forma farmaceutică:

TABLET

Compoziție:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE) 200MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2022-03-03

Caracteristicilor produsului

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-PAZOPANIB
Pazopanib tablets
Tablets, 200 mg pazopanib (as pazopanib hydrochloride), oral
Antineoplastic Agent
ATC Code: L01XE11
Pharmascience Inc.
Date of Initial Authorization:
6111 Royalmount Ave., suite 100
March 1, 2022
Montréal, Canada
H4P 2T4
www.pharmascience.com
Submission Control Number: 254544
_pms-PAZOPANIB – Product Monograph _
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RECENT MAJOR LABEL CHANGES
Not Applicable
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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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
......................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
................................................... 6
4.4
Administration
.................................................................................................
6
4.5
Missed Dose
.........................................................