LUPRON DEPOT POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LEUPROLIDE ACETATE

Disponibil de la:

ABBVIE CORPORATION

Codul ATC:

L02AE02

INN (nume internaţional):

LEUPRORELIN

Dozare:

30MG

Forma farmaceutică:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Compoziție:

LEUPROLIDE ACETATE 30MG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

1

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

GONADOTROPINS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2012-11-01

Caracteristicilor produsului

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_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
............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
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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