JAMP ATOMOXETINE CAPSULE
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
19-10-2020
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Aktiva substanser:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)
Tillgänglig från:
JAMP PHARMA CORPORATION
ATC-kod:
N06BA09
INN (International namn):
ATOMOXETINE
Dos:
40MG
Läkemedelsform:
CAPSULE
Sammansättning:
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 40MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Terapiområde:
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0150434004; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2020-10-20
Produktens egenskaper
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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