DEFERASIROX (TYPE J) TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DEFERASIROX

Tersedia dari:

JUBILANT GENERICS LIMITED

Kode ATC:

V03AC03

INN (Nama Internasional):

DEFERASIROX

Dosis:

180MG

Bentuk farmasi:

TABLET

Komposisi:

DEFERASIROX 180MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Ringkasan produk:

Active ingredient group (AIG) number: 0151733005; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2022-05-16

Karakteristik produk

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PRODUCT MONOGRAPH
PR
DEFERASIROX (TYPE J)
Deferasirox Tablets
90 mg, 180 mg and 360 mg
Iron chelating agent
MANUFACTURER:
Jubilant Generics Limited
1-A, Sector -16A, Institutional Area,
Noida -201301, Uttar Pradesh, India
IMPORTER / DISTRIBUTOR:
Pharmapar Inc.,
1565 Boul. Lionel-Boulet
Varennes QC J3X 1P7,
Canada
Date of Preparation:
May 13, 2022
CONTROL NO: 224461
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................3
INDICATIONS AND CLINICAL
USE..........................................................................3
CONTRAINDICATIONS..............................................................................................4
WARNINGS AND PRECAUTIONS
.............................................................................4
ADVERSE REACTIONS
..............................................................................................9
DRUG INTERACTIONS
............................................................................................
16
DOSAGE AND
ADMINISTRATION..........................................................................
18
OVERDOSAGE..........................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 22
STORAGE AND
STABILITY.....................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 24
PART II: SCIENTIFIC
INFORMATION............................................................................26
PHARMACEUTICAL INFORMATION
.....................................................................
26
CLINICAL
TRIALS.....................................................................................