Land: Canada
Sprog: engelsk
Kilde: Health Canada
LEUPROLIDE ACETATE
ABBVIE CORPORATION
L02AE02
LEUPRORELIN
5MG
SOLUTION
LEUPROLIDE ACETATE 5MG
SUBCUTANEOUS
1
Prescription
GONADOTROPINS
Active ingredient group (AIG) number: 0116959001; AHFS:
CANCELLED POST MARKET
2022-09-14
_ _ _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 ................................................... Læs hele dokumentet