Pays: Canada
Langue: anglais
Source: Health Canada
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)
TEVA CANADA LIMITED
N06BA09
ATOMOXETINE
60MG
CAPSULE
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 60MG
ORAL
30/100/500
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0150434005; AHFS:
APPROVED
2012-05-07
PRODUCT MONOGRAPH PR TEVA-ATOMOXETINE (atomoxetine capsules) 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg atomoxetine (as atomoxetine hydrochloride) Teva Standard Selective Norepinephrine Reuptake Inhibitor for Attention-Deficit/Hyperactivity Disorder (ADHD) Teva Canada Limited 30 Novopharm Court Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Submission Control No: 227394 Date of Revision: July 2, 2019 _TEVA-ATOMOXETINE Page 2 of 64_ 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 ......................................................................................................... 13 DRUG ABUSE AND DEPENDENCE .................................................................................... 24 DRUG INTERACTIONS ......................................................................................................... 24 DOSAGE AND ADMINISTRATION ..................................................................................... 26 OVERDOSAGE ....................................................................................................................... 30 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 30 STORAGE AND STABILITY ................................................................................................. 35 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 35 PART II: SCIENTIFIC INFORMATION ...................................... Lire le document complet