CALQUENCE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-11-2019
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Active ingredient:
ACALABRUTINIB
Available from:
ASTRAZENECA CANADA INC
ATC code:
L01EL02
INN (International Name):
ACALABRUTINIB
Dosage:
100MG
Pharmaceutical form:
CAPSULE
Composition:
ACALABRUTINIB 100MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0161750001; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-08-23
Summary of Product characteristics
_COPYRIGHT 2019 – ASTRAZENECA CANADA INC. _
_Page 1 of 41_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CALQUENCE
®
acalabrutinib capsules
Capsules, 100 mg, Oral
Antineoplastic Agent
AstraZeneca Canada Inc.
1004 Middlegate Road, Suite 5000
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Initial Approval:
August 22, 2019
Date of Revision:
November 28, 2019
Submission Control No: 231228
CALQUENCE
®
is a registered trademark of AstraZeneca AB, used under license by
AstraZeneca Canada Inc.
_ _
_COPYRIGHT 2019 – ASTRAZENECA CANADA INC. _
_Page 2 of 41_
RECENT MAJOR LABEL CHANGES
INDICATIONS (1)
11-2019
DOSAGE AND ADMINISTRATION, Recommended dose and dosage
adjustment (4.2)
11-2019
WARNINGS AND PRECAUTIONS, Cardiovascular (7)
11-2019
WARNINGS AND PRECAUTIONS, Hemorrhage (7)
11-2019
WARNINGS AND PRECAUTIONS, Immune (7)
11-2019
WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests (7)
11-2019
WARNINGS AND PRECAUTIONS, Pregnant Women (7.1.1)
11-2019
TABLE OF CONTENTS
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
....................................................
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