GD-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
24-01-2018
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Aktiva substanser:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)
Tillgänglig från:
GENMED A DIVISION OF PFIZER CANADA ULC
ATC-kod:
N06AX23
INN (International namn):
DESVENLAFAXINE
Dos:
50MG
Läkemedelsform:
TABLET (EXTENDED-RELEASE)
Sammansättning:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 50MG
Administreringssätt:
ORAL
Enheter i paketet:
7/14/28/30/90
Receptbelagda typ:
Prescription
Terapiområde:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0152509001; AHFS:
Bemyndigande status:
CANCELLED PRE MARKET
Tillstånd datum:
2020-04-02
Produktens egenskaper
PRODUCT MONOGRAPH
Pr
GD
*
-DESVENLAFAXINE
Desvenlafaxine Succinate
Extended Release Tablets 50 and 100 mg desvenlafaxine as
desvenlafaxine succinate
Antidepressant
GenMed, a Division of Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Preparation:
January 24, 2018
Submission Control No.: 212741
*
GD is a trademark of Pfizer Canada Inc.
GenMed, a division of Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc. 2017
_GD-Desvenlafaxine (desvenlafaxine succinate) Product Monograph _
_Page 2 of 51 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION................................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................3
INDICATIONS AND CLINICAL USE
................................................................................3
CONTRAINDICATIONS
......................................................................................................4
WARNINGS AND PRECAUTIONS
....................................................................................4
ADVERSE REACTIONS
....................................................................................................12
DRUG INTERACTIONS
....................................................................................................22
DOSAGE AND ADMINISTRATION
................................................................................26
OVERDOSAGE
...................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
...............................................................31
STORAGE AND STABILITY
............................................................................................35
SPECIAL HANDLING INSTRUCTIONS
..........................................................................35
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................35
PART II: SCIENTIFIC INFORMATION
.....................
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