FULVESTRANT INJECTION SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

FULVESTRANT

可用日期:

EUGIA PHARMA INC.

ATC代码:

L02BA03

INN（国际名称）:

FULVESTRANT

剂量:

50MG

药物剂型:

SOLUTION

组成:

FULVESTRANT 50MG

给药途径:

INTRAMUSCULAR

每包单位数:

100

处方类型:

Prescription

產品總結:

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

授权状态:

APPROVED

授权日期:

2023-03-28

产品特点

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