Land: Canada
Sprog: engelsk
Kilde: Health Canada
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)
PHARMEL INC
N06AX16
VENLAFAXINE
37.5MG
CAPSULE (EXTENDED RELEASE)
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 37.5MG
ORAL
100
Prescription
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0131294002; AHFS:
CANCELLED PRE MARKET
2017-09-13
PRODUCT MONOGRAPH PR PHL-VENLAFAXINE XR VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES 37.5 MG, 75 MG AND 150 MG VENLAFAXINE, AS VENLAFAXINE HYDROCHLORIDE Antidepressant PHARMEL INC. 6111 Royalmount Ave, Suite 100 Montréal, Québec H4P 2T4 DATE OF REVISION: February 28, 2013 Submission Control No: 116572, 151423, 162397 _ _ _phl-VENLAFAXINE XR Product Monograph _ _Page 2 of 54 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................15 DRUG INTERACTIONS ..................................................................................................23 DOSAGE AND ADMINISTRATION ..............................................................................30 OVERDOSAGE ................................................................................................................33 ACTION AND CLINICAL PHARMACOLOGY ............................................................34 STORAGE AND STABILITY ..........................................................................................37 SPECIAL HANDLING INSTRUCTIONS .......................................................................37 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................38 PART II: SCIENTIFIC INFORMATION ...............................................................................39 PHARMACEUTICAL INFORMATION ..........................................................................39 CLINICAL TR Læs hele dokumentet