Land: Kanada
Tungumál: enska
Heimild: Health Canada
ESCITALOPRAM (ESCITALOPRAM OXALATE)
LABORATOIRE RIVA INC.
N06AB10
ESCITALOPRAM
5MG
TABLET
ESCITALOPRAM (ESCITALOPRAM OXALATE) 5MG
ORAL
30/100/500
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0150435001; AHFS:
CANCELLED PRE MARKET
2020-10-16
PRODUCT MONOGRAPH PR RIVA-ESCITALOPRAM Escitalopram Oxalate Tablets 5 mg, 10 mg, 15 mg, 20 mg as Escitalopram ANTIDEPRESSANT / ANTIOBSESSIONAL LABORATOIRE RIVA INC 660 Industriel Blvd. Blainville, Quebec J7C 3V4 Date of Revision: October 03, 2016 www.labriva.com SUBMISSION CONTROL NO.: 198430 158 _RIVA-ESCITALOPRAM Product Monograph _ _Page 2 of 57_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................5 ADVERSE REACTIONS ..................................................................................................11 DRUG INTERACTIONS ..................................................................................................24 DOSAGE AND ADMINISTRATION ..............................................................................30 OVERDOSAGE ................................................................................................................32 ACTION AND CLINICAL PHARMACOLOGY ............................................................33 STORAGE AND STABILITY ..........................................................................................35 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................35 PART II: SCIENTIFIC INFORMATION ................................................................................37 PHARMACEUTICAL INFORMATION ..........................................................................37 CLINICAL TRIALS ..........................................................................................................38 DETAILED PHARMACOLOGY ... Lestu allt skjalið