Country: Canada
Language: English
Source: Health Canada
HYDROXYCHLOROQUINE SULFATE
MINT PHARMACEUTICALS INC
P01BA02
HYDROXYCHLOROQUINE
200MG
TABLET
HYDROXYCHLOROQUINE SULFATE 200MG
ORAL
100/500
Prescription
ANTIMALARIALS
Active ingredient group (AIG) number: 0107403001; AHFS:
APPROVED
2014-05-26
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MINT-HYDROXYCHLOROQUINE Hydroxychloroquine Sulfate Tablets Tablets, 200 mg, Oral USP Anti-Inflammatory – Antimalarial – Aminoquinolines Mint Pharmaceuticals Inc. 6575 Davand Drive Mississauga, Ontario L5T 2M3 Date of Initial Authorization: MAY 22, 2014 Date of Revision: MAY 5, 2023 Submission Control Number: 273056 _MINT-HYDROXYCHLOROQUINE (hydroxychloroquine sulfate tablets _ _Page 2 of 43 _ _ _ RECENT MAJOR LABEL CHANGES 2 Contraindications 05/2021 4 Dosage and Administration, Pregnant Women 11/2021 7 Warnings and Precautions, Hematologic 11/2021 7 Warnings and Precautions, Musculoskeletal 11/2021 7 Warnings and Precautions, Psychiatric 11/2021 7 Warnings and Precautions, Skin 01/2022 7 Warnings and Precautions, 7.1.1 Pregnant Women 11/2021 7 Warnings and Precautions, 7.1.4 Geriatrics 11/2021 7 Warning and Precautions, Cardiovascular 05/2023 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 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics ................................................................................................................... 4 1.2 Geriatrics ................................................................................................................... 4 CONTRAINDICATIONS ................................................................................................. 5 DOSAGE AND ADMINISTRATION ................................................................................. 5 4.1 Dosing Considerations: ...... Read the complete document