JAMP HYDROXYCHLOROQUINE SULFATE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

HYDROXYCHLOROQUINE SULFATE

Mevcut itibaren:

JAMP PHARMA CORPORATION

ATC kodu:

P01BA02

INN (International Adı):

HYDROXYCHLOROQUINE

Doz:

200MG

Farmasötik formu:

TABLET

Kompozisyon:

HYDROXYCHLOROQUINE SULFATE 200MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

ANTIMALARIALS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2019-08-09

Ürün özellikleri

_JAMP Hydroxychloroquine Sulfate (hydroxychloroquine sulfate tablets)_
Page 1 of 43_ _
_ _
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
..............................................................................................
5
4
DOSAGE AND ADMINISTRATION
........................................................