FULVESTRANT INJECTION SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-03-2023
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
FULVESTRANT
Available from:
EUGIA PHARMA INC.
ATC code:
L02BA03
INN (International Name):
FULVESTRANT
Dosage:
50MG
Pharmaceutical form:
SOLUTION
Composition:
FULVESTRANT 50MG
Administration route:
INTRAMUSCULAR
Units in package:
100
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0149744001; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-03-28
Summary of Product characteristics
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.................................................
Read the complete document
