CALQUENCE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ACALABRUTINIB (ACALABRUTINIB MALEATE)

Διαθέσιμο από:

ASTRAZENECA CANADA INC

Φαρμακολογική κατηγορία (ATC):

L01EL02

INN (Διεθνής Όνομα):

ACALABRUTINIB

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

ACALABRUTINIB (ACALABRUTINIB MALEATE) 100MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0161750001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2023-02-27

Αρχείο Π.Χ.Π.

_CALQUENCE_
_®_
_ Product Monograph _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CALQUENCE
®
acalabrutinib tablets
Tablets, 100 mg acalabrutinib (as acalabrutinib maleate), Oral
Antineoplastic agent
AstraZeneca Canada Inc.
1004 Middlegate Road, Suite 5000
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Initial Authorization:
FEB 24, 2023
Submission Control Number: 259246
CALQUENCE
®
is a registered trademark of AstraZeneca AB, used under license by
AstraZeneca Canada Inc. © AstraZeneca 2023.
_CALQUENCE_
_®_
_ Product Monograph _
_Page 2 of 42_
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
........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
...........................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.4
A