LUPRON SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

LEUPROLIDE ACETATE

Disponible des:

ABBVIE CORPORATION

Codi ATC:

L02AE02

Designació comuna internacional (DCI):

LEUPRORELIN

Dosis:

5MG

formulario farmacéutico:

SOLUTION

Composición:

LEUPROLIDE ACETATE 5MG

Vía de administración:

SUBCUTANEOUS

Unidades en paquete:

1

tipo de receta:

Prescription

Área terapéutica:

GONADOTROPINS

Resumen del producto:

Active ingredient group (AIG) number: 0116959001; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2022-09-14

Fitxa tècnica

_ _
_LUPRON/LUPRON DEPOT (leuprolide acetate) _
_November 18, 2021 _
_Submission Control No.: 254414 _
_Page 1 of 124_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LUPRON®
leuprolide acetate injection
5 mg/mL sterile solution subcutaneous injection
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 Previous Revision: NOV
23, 2020
Date of Revision:
NOV 18, 2021
Submission Control Number: 254414
_ _
_LUPRON/LUPRON DEPOT (leuprolide acetate) _
_November 18, 2021 _
_Submission Control No.: 254414 _
_Page 2 of 124_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, CENTRAL PRECOCIOUS
PUBERTY POPULATION (Only)
11/2021
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
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 6
1
INDICATIONS
.............................................................................................................
6
1.1
Pediatrics
..................................................................................................................
8
1.2
Geriatrics
...................................................