JAMP HYDROXYCHLOROQUINE SULFATE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

HYDROXYCHLOROQUINE SULFATE

Διαθέσιμο από:

JAMP PHARMA CORPORATION

Φαρμακολογική κατηγορία (ATC):

P01BA02

INN (Διεθνής Όνομα):

HYDROXYCHLOROQUINE

Δοσολογία:

200MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

HYDROXYCHLOROQUINE SULFATE 200MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTIMALARIALS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2019-08-09

Αρχείο Π.Χ.Π.

_JAMP Hydroxychloroquine Sulfate (hydroxychloroquine sulfate tablets)_
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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
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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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