FETZIMA CAPSULE (EXTENDED RELEASE)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

LEVOMILNACIPRAN (LEVOMILNACIPRAN HYDROCHLORIDE)

זמין מ:

ABBVIE CORPORATION

קוד ATC:

N06AX28

INN (שם בינלאומי):

LEVOMILNACIPRAN

כמות:

80MG

טופס פרצבטיות:

CAPSULE (EXTENDED RELEASE)

הרכב:

LEVOMILNACIPRAN (LEVOMILNACIPRAN HYDROCHLORIDE) 80MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS ANTIDEPRESSANTS

leaflet_short:

Active ingredient group (AIG) number: 0156890003; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2015-05-08

מאפייני מוצר

_FETZIMA (levomilnacipran) _
_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
FETZIMA®
Levomilnacipran Extended Release Capsules
Extended Release Capsule, 20 mg, 40 mg, 80 mg and 120 mg
levomilnacipran
(as levomilnacipran hydrochloride), oral
Antidepressant (ATC Code: N06AX)
AbbVie Corporation
8401 Trans-Canada Highway
Saint-Laurent, Quebec
H4S 1Z1
Date of Initial Authorization:
MAY 08, 2015
Date of Revision:
AUG 11, 2023
Submission Control Number: 272055
_ _
_FETZIMA (levomilnacipran) _
_Page 2 of 44 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS – 1.1 Pediatrics
08/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dose Adjustment,
Renal Impairment
08/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dose Adjustment,
Pediatric
08/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
08/2023
7 WARNINGS AND PRECAUTIONS, Cardiovascular, Elevated Blood Pressure
and
Hypertension
08/2023
7 WARNINGS AND PRECAUTIONS, Hematologic, Abnormal Bleeding
11/2021
7 WARNINGS AND PRECAUTIONS, Serotonin Toxicity / Serotonin Syndrome
11/2021
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Male and Female
Potential
11/2021
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant
Women
11/2021
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3 Pediatrics
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
......................................................................................................
2
TABLE OF CONTENTS
........................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................................
5
1
INDICATIONS
.......................................................................................................................
5
1.1
Pediatrics
...............................................................