HYDROXYCHLOROQUINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HYDROXYCHLOROQUINE SULFATE

Available from:

SANIS HEALTH INC

ATC code:

P01BA02

INN (International Name):

HYDROXYCHLOROQUINE

Dosage:

200MG

Pharmaceutical form:

TABLET

Composition:

HYDROXYCHLOROQUINE SULFATE 200MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTIMALARIALS

Product summary:

Active ingredient group (AIG) number: 0107403001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-08-26

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
HYDROXYCHLOROQUINE
Hydroxychloroquine Sulfate Tablets
Tablets, 200 mg, Oral
USP
Anti-Inflammatory – Antimalarial – Aminoquinolines
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
AUG 26, 2021
Date of Revision:
JUL 19, 2023
Submission Control Number: 276674
_HYDROXYCHLOROQUINE (hydroxychloroquine sulfate tablets _
_Page 2 of 43 _
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RECENT MAJOR LABEL CHANGES
2 Contraindications
08/2021
4 Dosage and Administration, Pregnant Women
02/2022
7 Warnings and Precautions, Hematologic
02/2022
7 Warnings and Precautions, Musculoskeletal
02/2022
7 Warnings and Precautions, Psychiatric
02/2022
7 Warnings and Precautions, Skin
03/2023
7 Warnings and Precautions, 7.1.1 Pregnant Women
02/2022
7 Warnings and Precautions, 7.1.4 Geriatrics
02/2022
7 Warning and Precautions, Cardiovascular
07/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
CONTRAINDICATIONS
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5
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations:
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