VOTRIENT TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE)

Boleh didapati daripada:

NOVARTIS PHARMACEUTICALS CANADA INC

Kod ATC:

L01EX03

INN (Nama Antarabangsa):

PAZOPANIB

Dos:

400MG

Borang farmaseutikal:

TABLET

Komposisi:

PAZOPANIB (PAZOPANIB HYDROCHLORIDE) 400MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/60

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0152743002; AHFS:

Status kebenaran:

CANCELLED PRE MARKET

Tarikh kebenaran:

2020-07-08

Ciri produk

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_Page 1 of 53 _
PRODUCT MONOGRAPH
PR VOTRIENT
®
Pazopanib (as pazopanib hydrochloride)
Tablets, 200 mg and 400 mg
Antineoplastic Agent
Submission Control No: 234074
VOTRIENT is a registered trademark
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
Date of Revision:
February 28, 2020
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_Page 2 of 53 _
TABLE OF CONTENTS
PAGE
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................
5
ADVERSE REACTIONS
..........................................................................................
15
DRUG INTERACTIONS
..........................................................................................
24
DOSAGE AND ADMINISTRATION
.........................................................................
28
OVERDOSAGE
.......................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 30
STORAGE AND STABILITY
...................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 33
PART II: SCIENTIFIC INFORMATION
..........................................................................
34
PHARMACEUTICAL INFORMATION
.....................................................................
34
CLINICAL TRIALS
.................................................................................................
34
DETAILED PHARMACOLOGY
.........................................................