PMS-ANAGRELIDE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ANAGRELIDE (ANAGRELIDE HYDROCHLORIDE MONOHYDRATE)

Available from:

PHARMASCIENCE INC

ATC code:

L01XX35

INN (International Name):

ANAGRELIDE

Dosage:

0.5MG

Pharmaceutical form:

CAPSULE

Composition:

ANAGRELIDE (ANAGRELIDE HYDROCHLORIDE MONOHYDRATE) 0.5MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

PLATELET-REDUCING AGENTS

Product summary:

Active ingredient group (AIG) number: 0131875001; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-01-06

Summary of Product characteristics

_pms-ANAGRELIDE (anagrelide hydrochloride) _
_Page 1 of 37_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-ANAGRELIDE
Anagrelide Hydrochloride Capsules
Capsules, 0.5 mg anagrelide (as anagrelide hydrochloride monohydrate),
Oral
House Standard
Platelet-Reducing Agent
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite #100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 274306
Submission Control No: 236846
Date of Initial Authorization:
January 6, 2006
Date of Revision:
October 3, 2023
_pms-ANAGRELIDE (anagrelide hydrochloride) _
_Page 2 of 37_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
09/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
09/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
09/2023
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
03/2022
7 WARNINGS AND PRECAUTIONS
03/2022
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
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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
................................................................... 5
4
DOSAGE AND ADMINISTRATION
....................................