FYCOMPA TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

PERAMPANEL

Предлага се от:

EISAI LIMITED

АТС код:

N03AX22

INN (Международно Name):

PERAMPANEL

дозиране:

2MG

Лекарствена форма:

TABLET

Композиция:

PERAMPANEL 2MG

Начин на приложение:

ORAL

Броя в опаковка:

7/30/90

Вид предписание :

Prescription

Терапевтична област:

MISCELLANEOUS ANTICONVULSANTS

Каталог на резюме:

Active ingredient group (AIG) number: 0154211001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2013-04-04

Данни за продукта

_ _
_FYCOMPA_
®
_(Perampanel)_
_ _
_Page 1 of 55 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
FYCOMPA
®
Perampanel Tablets
Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg, Oral
Professed Standard
Antiepileptic Agent
ATC Code: N03AX22
Eisai Limited
6925 Century Avenue, Suite 701
Mississauga, Ontario
L5N 7K2
Eisai.ca
Date of Initial Authorization:
Apr 4, 2013
Date of Revision:
Nov 16, 2023
FYCOMPA® is a registered trademark owned by Eisai R&D Management Co.,
Ltd.
Submission Control No: 275884
_ _
_FYCOMPA_
®
_(Perampanel)_
_ _
_Page 2 of 55 _
_ _
RECENT MAJOR LABEL CHANGES
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
......................................................................
3
1
INDICATIONS
...............................................................................................................
3
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.3
Administration
..