AG-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-02-2022
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Active ingredient:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)
Available from:
ANGITA PHARMA INC.
ATC code:
N06AX23
INN (International Name):
DESVENLAFAXINE
Dosage:
50MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 50MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0152509001; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-03-04
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
AG-DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
50 and 100 mg desvenlafaxine (as desvenlafaxine succinate monohydrate)
Antidepressant
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3
SUBMISSION CONTROL NO.: 260512
_AG-DESVENLAFAXINE (desvenlafaxine succinate) Product Monograph _
_Page 1 of 57_
Date of Revision:
February
28, 2022
_AG-DESVENLAFAXINE (desvenlafaxine succinate) Product Monograph_
_Page 2 of 57_
_ _
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
....................................................................................................
13
DRUG INTERACTIONS
....................................................................................................24
DOSAGE AND ADMINISTRATION
................................................................................28
OVERDOSAGE
...................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
...............................................................33
STORAGE AND STABILITY
............................................................................................37
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................37
PART II: SCIENTIFIC INFORMATION
..................................................................................
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