VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
30-05-2012
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Aktiva substanser:
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)
Tillgänglig från:
TEVA CANADA LIMITED
ATC-kod:
N06AX16
INN (International namn):
VENLAFAXINE
Dos:
75MG
Läkemedelsform:
CAPSULE (EXTENDED RELEASE)
Sammansättning:
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 75MG
Administreringssätt:
ORAL
Enheter i paketet:
100/500
Receptbelagda typ:
Prescription
Terapiområde:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0131294001; AHFS:
Bemyndigande status:
CANCELLED PRE MARKET
Tillstånd datum:
2015-10-16
Produktens egenskaper
PRODUCT MONOGRAPH
PR
VENLAFAXINE XR
(venlafaxine hydrochloride extended release capsules)
37.5 mg, 75 mg and 150 mg venlafaxine (as venlafaxine hydrochloride)
Antidepressant / Anxiolytic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 155222
Date of Preparation: May 11, 2012
_Page 2_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT
INFORMATION.........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS....................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE
REACTIONS..................................................................................................19
DRUG INTERACTIONS
..................................................................................................38
DOSAGE AND ADMINISTRATION
..............................................................................43
OVERDOSAGE.................................................................................................................47
ACTION AND CLINICAL
PHARMACOLOGY.............................................................49
STORAGE AND STABILITY
..........................................................................................52
SPECIAL HANDLING
INSTRUCTIONS........................................................................52
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................52
PART II: SCIENTIFIC INFORMATION
...............................................................................53
PHARMACEUTICAL
INFORMATION..........................................................................53
CLINICAL TRIALS
..............................................................
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