국가: 캐나다
언어: 영어
출처: Health Canada
LEUPROLIDE ACETATE
ABBVIE CORPORATION
L02AE02
LEUPRORELIN
7.5MG
POWDER FOR SUSPENSION, SUSTAINED-RELEASE
LEUPROLIDE ACETATE 7.5MG
INTRAMUSCULAR
1
Prescription
GONADOTROPINS
Active ingredient group (AIG) number: 0116959002; AHFS:
APPROVED
2012-11-01
_ _ _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 .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 5 1 INDICATIONS ............................................................................................................... 5 1.1 Pediatrics ................................................................................................................ 6 1.2 Geriatrics ................................................................................................................ 6 2 CONTRAINDICATIONS ................................................................................................. 6 3 SERIOUS WARNINGS A 전체 문서 읽기