JAMP ATOMOXETINE CAPSULE
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
19-10-2020
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Ingredient activ:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)
Disponibil de la:
JAMP PHARMA CORPORATION
Codul ATC:
N06BA09
INN (nume internaţional):
ATOMOXETINE
Dozare:
40MG
Forma farmaceutică:
CAPSULE
Compoziție:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 40MG
Calea de administrare:
ORAL
Unități în pachet:
15G/50G
Tip de prescriptie medicala:
Prescription
Zonă Terapeutică:
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Rezumat produs:
Active ingredient group (AIG) number: 0150434004; AHFS:
Statutul autorizaţiei:
APPROVED
Data de autorizare:
2020-10-20
Caracteristicilor produsului
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
........................................................
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