Страна: Канада
Язык: английский
Источник: Health Canada
DULOXETINE (DULOXETINE HYDROCHLORIDE)
TEVA CANADA LIMITED
N06AX21
DULOXETINE
30MG
CAPSULE (DELAYED RELEASE)
DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG
ORAL
30/100
Prescription
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0152350001; AHFS:
CANCELLED PRE MARKET
2021-07-29
_ _ _TEVA-DULOXETINE _ _Page 1 of 81_ PRODUCT MONOGRAPH PR TEVA-DULOXETINE Duloxetine Delayed Release Capsules, Mfr. Std. Duloxetine (as duloxetine hydrochloride) 30 mg and 60 mg ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Date of Preparation: August 21, 2019 Date of Revision: August 29, 2019 Submission Control No: 230092 _ _ _TEVA-DULOXETINE _ _Page 2 of 81_ 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 ................................................................................................. 19 DRUG INTERACTIONS ................................................................................................. 37 DOSAGE AND ADMINISTRATION ............................................................................. 41 OVERDOSAGE ............................................................................................................... 44 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 45 STORAGE AND STABILITY ......................................................................................... 48 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 49 PART II: SCIENTIFIC INFORMATION ............................................................................... 50 PHARMACEUTICAL INFORMATION ......................................................................... 50 CLINICAL TRIALS .................................................................... Прочитать полный документ