AG-PAROXETINE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE)

Διαθέσιμο από:

ANGITA PHARMA INC.

Φαρμακολογική κατηγορία (ATC):

N06AB05

INN (Διεθνής Όνομα):

PAROXETINE

Δοσολογία:

20MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) 20MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0123131002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-05-09

Αρχείο Π.Χ.Π.

_AG-Paroxetine, paroxetine hydrochloride_
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_Page 1 of 57_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AG-PAROXETINE
Paroxetine Tablets
Tablets, 10 mg, 20 mg and 30 mg paroxetine (as paroxetine
hydrochloride hemihydrate), Oral
USP
Selective Serotonin Reuptake Inhibitor
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
May 09, 2018
Date of Revision:
September 29, 2023
Submission Control Number: 278985
_AG-Paroxetine, paroxetine hydrochloride_
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_Page 2 of 57_
_ _
RECENT MAJOR LABEL CHANGES
SECTION
DATE
7 WARNINGS AND PRECAUTIONS, Cardiovascular
09/2023
7 WARNINGS AND PRECAUTIONS, Hematologic
08/2022
7 WARNINGS AND PRECAUTIONS, Immune
08/2022
7 WARNINGS AND PRECAUTIONS, Neurologic
08/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
08/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female
and Male Potential
08/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
08/2022
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
.....................................................................
5
1
INDICATIONS
.............................................................................................................
5
1.1
Pediatrics
..................................................................................................................
5
1.2
Geriatrics
...................................................................................................................
5
2
CONTRAINDICATIONS
................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................