AG-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)

Mevcut itibaren:

ANGITA PHARMA INC.

ATC kodu:

N06AX23

INN (International Adı):

DESVENLAFAXINE

Doz:

50MG

Farmasötik formu:

TABLET (EXTENDED-RELEASE)

Kompozisyon:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 50MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Ürün özeti:

Active ingredient group (AIG) number: 0152509001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2022-03-04

Ürün özellikleri

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
..................................................................................