Država: Kanada
Jezik: engleski
Izvor: Health Canada
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)
TEVA CANADA LIMITED
N06AX16
VENLAFAXINE
150MG
CAPSULE (EXTENDED RELEASE)
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 150MG
ORAL
100/500
Prescription
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0131294005; AHFS:
CANCELLED PRE MARKET
2015-10-16
PRODUCT MONOGRAPH PR VENLAFAXINE XR (venlafaxine hydrochloride extended release capsules) 37.5 mg, 75 mg and 150 mg venlafaxine (as venlafaxine hydrochloride) Antidepressant / Anxiolytic Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Submission Control No: 155222 Date of Preparation: May 11, 2012 _Page 2_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION.........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS....................................................................................................5 WARNINGS AND PRECAUTIONS ..................................................................................6 ADVERSE REACTIONS..................................................................................................19 DRUG INTERACTIONS ..................................................................................................38 DOSAGE AND ADMINISTRATION ..............................................................................43 OVERDOSAGE.................................................................................................................47 ACTION AND CLINICAL PHARMACOLOGY.............................................................49 STORAGE AND STABILITY ..........................................................................................52 SPECIAL HANDLING INSTRUCTIONS........................................................................52 DOSAGE FORMS, COMPOSITION AND PACKAGING..............................................52 PART II: SCIENTIFIC INFORMATION ...............................................................................53 PHARMACEUTICAL INFORMATION..........................................................................53 CLINICAL TRIALS .............................................................. Pročitajte cijeli dokument