Land: Canada
Sprog: engelsk
Kilde: Health Canada
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)
APOTEX INC
N06BA09
ATOMOXETINE
60MG
CAPSULE
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 60MG
ORAL
30/100/1000
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0150434005; AHFS:
APPROVED
2010-09-21
Page 1 of 60 PRODUCT MONOGRAPH PR APO-ATOMOXETINE ATOMOXETINE HYDROCHLORIDE CAPSULES 10 MG, 18 MG, 25 MG, 40 MG, 60 MG, 80 MG AND 100 MG* *ATOMOXETINE AS ATOMOXETINE HYDROCHLORIDE SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR FOR ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD) APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 DATE OF REVISION: January 8, 2016 SUBMISSION CONTROL NO: 190898 Page 2 of 60 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 ......................................................................... 23 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 ............................................................... 37 PHARMACEUTICAL INFORMATION ..................................................................... 37 CLINICAL TRIALS ............................................................... Læs hele dokumentet