Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)
BGP PHARMA ULC
N06AX16
VENLAFAXINE
37.5MG
CAPSULE (EXTENDED RELEASE)
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 37.5MG
ORAL
15G/50G
Prescription
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0131294002; AHFS:
APPROVED
2003-03-04
_EFFEXOR XR (venlafaxine hydrochloride) _ _Page 1 of 71_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR EFFEXOR® XR Venlafaxine Hydrochloride Extended Release Capsules Extended Release Capsules, 37.5 mg, 75 mg and 150 mg venlafaxine (as venlafaxine hydrochloride), Oral Mfr. Std. Antidepressant/Anxiolytic BGP Pharma ULC 85 Advance Road Etobicoke, Ontario M8Z 2S6 Date of Initial Authorization: AUG 09, 2023 Date of Revision: OCT 31, 2023 Submission Control Number: 276199 ® Viatris Specialty LLC _ _ _EFFEXOR XR (venlafaxine hydrochloride) _ _Page 2 of 71_ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS 10/2023 4.9 Discontinuation 10/2023 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 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 4.1 Dosing Considerations ............................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment ............ Izlasiet visu dokumentu