NAT-SUNITINIB CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SUNITINIB (SUNITINIB MALATE)

Disponible depuis:

NATCO PHARMA (CANADA) INC

Code ATC:

L01EX01

DCI (Dénomination commune internationale):

SUNITINIB

Dosage:

50MG

forme pharmaceutique:

CAPSULE

Composition:

SUNITINIB (SUNITINIB MALATE) 50MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Descriptif du produit:

Active ingredient group (AIG) number: 0151642003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2023-06-30

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
NAT-SUNITINIB
Sunitinib capsules
Capsules, 50 mg sunitinib (as sunitinib malate), Oral
Tyrosine Kinase Inhibitor, Anti-Tumour Agent
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, Suite 200
Mississauga, Ontario
L5N 1P7
Date of Initial Authorization:
June 29, 2023
Submission Control No.: 254828
_NAT-SUNITINIB Product Monograph _
_Page 2 of 69 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
17
DRUG INTERACTIONS
.................................................................................................
32
DOSAGE AND ADMINISTRATION
.............................................................................
33
OVERDOSAGE
................................................................................................................
34
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 34
STORAGE AND STABILITY
.........................................................................................
38
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 39
PART II: SCIENTIFIC
INFORMATION...............................................................................
40
PHARMACEUTICAL INFORMATION
.........................................................................
40
CLINICAL TRIALS
...