JAMP HYDROXYCHLOROQUINE SULFATE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

HYDROXYCHLOROQUINE SULFATE

Disponible depuis:

JAMP PHARMA CORPORATION

Code ATC:

P01BA02

DCI (Dénomination commune internationale):

HYDROXYCHLOROQUINE

Dosage:

200MG

forme pharmaceutique:

TABLET

Composition:

HYDROXYCHLOROQUINE SULFATE 200MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTIMALARIALS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2019-08-09

Résumé des caractéristiques du produit

_JAMP Hydroxychloroquine Sulfate (hydroxychloroquine sulfate tablets)_
Page 1 of 43_ _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate Tablets
Tablets, 200 mg, Oral
USP
Anti-Inflammatory – Antimalarial – Aminoquinolines
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
August 09, 2019
Date of Revision:
June 22, 2023
Submission Control No.: 274020
_JAMP Hydroxychloroquine Sulfate (hydroxychloroquine sulfate tablets)_
Page 2 of 43_ _
_ _
RECENT MAJOR LABEL CHANGES
2 Contraindications
06/2023
7 Warnings and Precautions, Hematologic
06/2023
7 Warnings and Precautions, Musculoskeletal
06/2023
7 Warnings and Precautions, Psychiatric
06/2023
7 Warnings and Precautions, 7.1.4 Geriatrics
06/2023
7 Warnings and Precautions, 7.1.1 Pregnant Women
06/2023
7 Warning and Precautions, Skin
06/2023
7 Warning and Precautions, Cardiovascular
06/2023
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
1
INDICATIONS............................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATION
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