AG-ATOMOXETINE CAPSULE
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
26-11-2020
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ingredients actius:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)
Disponible des:
ANGITA PHARMA INC.
Codi ATC:
N06BA09
Designació comuna internacional (DCI):
ATOMOXETINE
Dosis:
80MG
formulario farmacéutico:
CAPSULE
Composición:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 80MG
Vía de administración:
ORAL
Unidades en paquete:
100
tipo de receta:
Prescription
Área terapéutica:
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Resumen del producto:
Active ingredient group (AIG) number: 0150434006; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2020-11-30
Fitxa tècnica
AG-ATOMOXETINE Product Monograph
Page 1
PRODUCT MONOGRAPH
PR
AG-ATOMOXETINE
Atomoxetine Capsules
10, 18, 25, 40, 60, 80 and 100 mg atomoxetine (as atomoxetine
hydrochloride)
House standard
SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR
FOR ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
Angita Pharma Inc.
1310, rue Nobel
Boucherville, Québec
J4B 5H3
Date of Revision:
November 26, 2020
Submission Control No. 245703
AG-ATOMOXETINE Product Monograph
Page 2
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
.................................................................................................
12
DRUG ABUSE AND DEPENDENCE
............................................................................
22
DRUG INTERACTIONS
..................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
24
OVERDOSAGE
.................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 28
STORAGE AND STABILITY
.........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 33
PART II: SCIENTIFIC INFORMATION
............................................................................
34
PHARMACEUTICAL INFORMATION
........................
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