LUPRON DEPOT POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LEUPROLIDE ACETATE

Available from:

ABBVIE CORPORATION

ATC code:

L02AE02

INN (International Name):

LEUPRORELIN

Dosage:

30MG

Pharmaceutical form:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Composition:

LEUPROLIDE ACETATE 30MG

Administration route:

INTRAMUSCULAR

Units in package:

1

Prescription type:

Prescription

Therapeutic area:

GONADOTROPINS

Product summary:

Active ingredient group (AIG) number: 0116959007; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-11-01

Summary of Product characteristics

_ _
_LUPRON DEPOT (leuprolide acetate) _
_Page 1 of 100 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LUPRON DEPOT®
leuprolide acetate for depot suspension
3.75 mg/syringe (1-Month slow release), 7.5 mg/syringe (1-Month slow
release),
11.25 mg/syringe (3-Month slow release), 22.5 mg/syringe (3-Month slow
release),
30 mg/syringe (4-Month slow release)
pre-filled dual-chamber syringe containing sterile lyophilized
microspheres intramuscular injection
Gonadotropin-releasing hormone analog (ATC: L02AE02)
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, QC H4S 1Z1
Date of Initial Authorization:
•
Central Precocious Puberty:
NOV 26, 1986
•
Prostate Cancer: MAR 11,
1999
•
Endometriosis: MAR 11, 1999
•
Uterine Fibroids: FEB 07,
2017
Date of Revision: MAR 19, 2024
Submission Control Number: 280431
_ _
_LUPRON DEPOT (leuprolide acetate) _
_Page 2 of 100 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, PROSTATE CANCER
POPULATION (Only)
01/2024
7 WARNINGS AND PRECAUTIONS, ALL POPULATIONS
03/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
...............................................................................................................
5
1.1
Pediatrics
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6
1.2
Geriatrics
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6
2
CONTRAINDICATIONS
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6
3
SERIOUS WARNINGS A