FULVESTRANT INJECTION SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

FULVESTRANT

MAH:

EUGIA PHARMA INC.

ATC_code:

L02BA03

INN:

FULVESTRANT

dosage:

50MG

pharmaceutical_form:

SOLUTION

composition:

FULVESTRANT 50MG

administration_route:

INTRAMUSCULAR

units_in_package:

100

prescription_type:

Prescription

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2023-03-28

SPC

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