AG-HYDROXYCHLOROQUINE TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

HYDROXYCHLOROQUINE SULFATE

Prieinama:

ANGITA PHARMA INC.

ATC kodas:

P01BA02

INN (Tarptautinis Pavadinimas):

HYDROXYCHLOROQUINE

Dozė:

200MG

Vaisto forma:

TABLET

Sudėtis:

HYDROXYCHLOROQUINE SULFATE 200MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100

Recepto tipas:

Prescription

Gydymo sritis:

ANTIMALARIALS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2021-01-19

Prekės savybės

_AG-Hydroxychloroquine (hydroxychloroquine sulfate tablets) _ Page 1
of 44
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-HYDROXYCHLOROQUINE
Hydroxychloroquine Sulfate Tablets
Tablets, 200 mg, Oral
USP
Anti-Inflammatory – Antimalarial – Aminoquinolines
Angita Pharma Inc.
1310, rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
JAN 19, 2021
Date of Revision:
APR 27, 2023
Submission Control Number: 273645
_AG-Hydroxychloroquine (hydroxychloroquine sulfate tablets) _ Page 2
of 44
RECENT MAJOR LABEL CHANGES
2 Contraindications
04/2023
4 Dosage and Administration, Pregnant Women
04/2023
7 Warnings and Precautions, Hematologic
04/2023
7 Warnings and Precautions, Musculoskeletal
04/2023
7 Warnings and Precautions, Psychiatric
04/2023
7 Warnings and Precautions, 7.1.4 Geriatrics
04/2023
7 Warnings and Precautions, 7.1.1 Pregnant Women
04/2023
7 Warning and Precautions, Skin
04/2023
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
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considera