SANDOZ DESVENLAFAXINE TABLET (EXTENDED-RELEASE)

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

DESVENLAFAXINE

Beszerezhető a:

SANDOZ CANADA INCORPORATED

ATC-kód:

N06AX23

INN (nemzetközi neve):

DESVENLAFAXINE

Adagolás:

100MG

Gyógyszerészeti forma:

TABLET (EXTENDED-RELEASE)

Összetétel:

DESVENLAFAXINE 100MG

Az alkalmazás módja:

ORAL

db csomag:

100

Recept típusa:

Prescription

Termék összefoglaló:

Active ingredient group (AIG) number: 0152509002; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2023-05-29

Termékjellemzők

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_Sandoz Desvenlafaxine _
_Page 1 of 53_
PRODUCT MONOGRAPH
PR
SANDOZ DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
Tablets, 50 and 100 mg, oral
Antidepressant
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec, Canada
J4B 1E6
Date of Preparation:
May 26, 2023
Submission Control No: 257049
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_Sandoz Desvenlafaxine _
_Page 2 of 53_
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
.................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
26
OVERDOSAGE
................................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 30
STORAGE AND STABILITY
.........................................................................................
34
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
34
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 34
PART II: SCIENTIFIC INFORMATION
..............................................................................
35
PHARMACEUTICAL INFORMATION
.........................................................................
35
CLINICAL TRIALS
..........................