AURO-ATOMOXETINE CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Commercializzato da:

AURO PHARMA INC

Codice ATC:

N06BA09

INN (Nome Internazionale):

ATOMOXETINE

Dosaggio:

25MG

Forma farmaceutica:

CAPSULE

Composizione:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 25MG

Via di somministrazione:

ORAL

Confezione:

2X10 / 2X14 /30/100/500

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0150434003; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2018-01-05

Scheda tecnica

Page 1 of 53
PRODUCT MONOGRAPH
PR
AURO-ATOMOXETINE
ATOMOXETINE CAPSULES
10 MG, 18 MG, 25 MG, 40 MG, 60 MG, 80 MG AND 100 MG
(as atomoxetine hydrochloride)
HOUSE STANDARD
SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR
FOR ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Preparation:
January 3, 2018
Submission Control No
:
201452
Page 2 of 53
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
.........................................................................
21
DRUG
INTERACTIONS..............................................................................................
22
DOSAGE AND ADMINISTRATION
..........................................................................
23
OVERDOSAGE
............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 27
STORAGE AND STABILITY
.....................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 32
PART II: SCIENTIFIC INFORMATION
.........................................................................
33
PHARMACEUTICAL INFORMATION
.....................................................................
33
CLINICAL TRIA