JAMP ATOMOXETINE CAPSULE

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Disponível em:

JAMP PHARMA CORPORATION

Código ATC:

N06BA09

DCI (Denominação Comum Internacional):

ATOMOXETINE

Dosagem:

60MG

Forma farmacêutica:

CAPSULE

Composição:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 60MG

Via de administração:

ORAL

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Área terapêutica:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0150434005; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2020-10-20

Características técnicas

JAMP ATOMOXETINE
Product Monograph
Page 1
PRODUCT MONOGRAPH
PR
JAMP 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)
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Québec
J4B 5H3
Date of Approval:
October 19, 2020
Submission Control No 235031
JAMP 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
........................................................