País: Canadà
Idioma: anglès
Font: Health Canada
PAROXETINE (PAROXETINE HYDROCHLORIDE)
JAMP PHARMA CORPORATION
N06AB05
PAROXETINE
30MG
TABLET
PAROXETINE (PAROXETINE HYDROCHLORIDE) 30MG
ORAL
100/1000
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0123131001; AHFS:
APPROVED
2020-11-17
_JAMP Paroxetine Tablets ( paroxetine hydrochloride) _ _Page 1 of 64_ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR JAMP PAROXETINE TABLETS Paroxetine Tablets Tablets, 10 mg, 20 mg and 30 mg paroxetine (as paroxetine hydrochloride), Oral USP Selective Serotonin Reuptake Inhibitor JAMP Pharma Corporation 1310, rue Nobel Boucherville, Quebec J4B 5H3, Canada Date of Initial Authorization: November 17, 2020 Date of Revision: April 27, 2023 Submission Control Number: 269630 _JAMP Paroxetine Tablets ( paroxetine hydrochloride) _ _Page 2 of 64_ _ _ RECENT MAJOR LABEL CHANGES SECTION DATE 7 WARNINGS AND PRECAUTIONS, Cardiovascular 04/2023 7 WARNINGS AND PRECAUTIONS, Hematologic 09/2022 7 WARNINGS AND PRECAUTIONS, Immune 09/2022 7 WARNINGS AND PRECAUTIONS, Neurologic 09/2022 7 WARNINGS AND PRECAUTIONS, Psychiatric 09/2022 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 09/2022 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 09/2022 2 CONTRAINDICATIONS 09/2022 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 ... Llegiu el document complet