FERRIPROX TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DEFERIPRONE

Tersedia dari:

CHIESI CANADA CORP.

Kode ATC:

V03AC02

INN (Nama Internasional):

DEFERIPRONE

Dosis:

1000MG

Bentuk farmasi:

TABLET

Komposisi:

DEFERIPRONE 1000MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

HEAVY METAL ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0156430003; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-03-12

Karakteristik produk

_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
..............................................................................................