FULVESTRANT INJECTION SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

FULVESTRANT

Доступна з:

EUGIA PHARMA INC.

Код атс:

L02BA03

ІПН (Міжнародна Ім'я):

FULVESTRANT

Дозування:

50MG

Фармацевтична форма:

SOLUTION

Склад:

FULVESTRANT 50MG

Адміністрація маршрут:

INTRAMUSCULAR

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Огляд продуктів:

Active ingredient group (AIG) number: 0149744001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2023-03-28

Характеристики продукта

Page 1 of 37
PRODUCTMONOGRAPH
Pr
FulvestrantInjection
50 mg/mL
Intramuscular
Nonagonist EstrogenReceptor Antagonist
EugiaPharma Inc.
3700 SteelesAvenueWest,Suite # 402
Woodbridge,Ontario
L4L8K8
SubmissionControlNo.: 272653
Date of Preparation:
MAR 28, 2023
Page 2 of 37
Table of Contents
PARTI: HEALTH PROFESSIONAL INFORMATION
................................................3
SUMMARY PRODUCT INFORMATION
......................................................................3
INDICATIONSAND CLINICAL
USE............................................................................3
CONTRAINDICATIONS
.................................................................................................3
WARNINGS AND PRECAUTIONS
...............................................................................3
ADVERSE REACTIONS
.................................................................................................6
DRUG INTERACTIONS
...............................................................................................12
DOSAGE AND
ADMINISTRATION............................................................................12
OVERDOSAGE..............................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
..........................................................15
STORAGE AND STABILITY
.......................................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................17
PARTII:
SCIENTIFIC INFORMATION
.....................................................................19
PHARMACEUTICAL INFORMATION
.......................................................................19
CLINICAL TRIALS
.......................................................................................................19
DETAILEDPHARMACOLOGY...................................................................................30
TOXICOLOGY.................................................