Ország: Kanada
Nyelv: angol
Forrás: Health Canada
DEFERIPRONE
CHIESI CANADA CORP.
V03AC02
DEFERIPRONE
1000MG
TABLET (EXTENDED-RELEASE)
DEFERIPRONE 1000MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0156430003; AHFS:
APPROVED
2023-03-29
_Product Monograph Master Template _ _Template Date: September 2020 _ _FERRIPROX deferiprone, FERRIPROX MR deferiprone _ _Page 1 of 54_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr FERRIPROX Deferiprone Tablets, Ph.Eur. 500 mg and 1 000 mg Deferiprone Oral Solution, Ph.Eur. 100 mg/mL Pr FERRIPROX MR Deferiprone Extended-Release Tablets 1 000 mg Iron Chelating Agent Chiesi Canada Corp. 100E - 3800 Steeles Avenue West, Woodbridge, ON L4L 4G9 Date of Initial Authorization February 13, 2015 Date of Revision: March 29, 2023 Submission Control No: 261912 _ _ _Product Monograph Master Template _ _Template Date: September 2020 _ _FERRIPROX deferiprone, FERRIPROX MR deferiprone _ _Page 2 of 54_ RECENT MAJOR LABEL CHANGES 1 Indications 2021-10 1 Indications, 1.1 Pediatrics 2021-10 4 Dosage and Administration, 4.1 Dosing Considerations 2023-03 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 2023-03 4 Dosage and Administration, 4.4 Administration 2023-03 7 Warnings and Precautions, Hepatic/Biliary/Pancreatic 2021-10 7 Warnings and Precautions, Reproductive Health: Female and Male Potential 2023-13 7 Warnings and Precautions, 7.1.3 Pediatrics 2021-10 _Product Monograph Master Template _ _Template Date: September 2020 _ _FERRIPROX deferiprone, FERRIPROX MR deferiprone _ _Page 3 of 54_ 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 .............................................................................................................. 3 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 5 1. INDICATIONS ............................................................................................................... 5 1.1 Pediatrics .............................................................................................. Olvassa el a teljes dokumentumot