ISTODAX KIT

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ROMIDEPSIN

Tersedia dari:

BRISTOL-MYERS SQUIBB CANADA

Kode ATC:

L01XH02

INN (Nama Internasional):

ROMIDEPSIN

Dosis:

10MG

Bentuk farmasi:

KIT

Komposisi:

ROMIDEPSIN 10MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

1

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0154830001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2013-10-16

Karakteristik produk

_ISTODAX (romidepsin) _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ISTODAX®
romidepsin for injection
Lyophilized powder for solution, 10 mg/vial, intravenous infusion
Antineoplastic Agent
Histone Deacetylase (HDAC) Inhibitor
ISTODAX® (romidepsin) is indicated for:
•
the treatment of patients with relapsed/refractory peripheral T-cell
lymphoma (PTCL) who
are not eligible for transplant and have received at least one prior
systemic therapy
has been issued market authorization with conditions. The clinical
benefit of ISTODAX in the
relapsed/refractory PTCL setting remains unconfirmed. Patients and
Health Care Professionals
should be advised of the Restricted Access Program. ISTODAX should not
be initiated in new patients
outside of an investigational setting. For further information for
ISTODAX please refer to Health
Canada’s Notice of Compliance with conditions - drug products web
site:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-
compliance/conditions.html
Bristol-Myers Squibb Canada
2344 Alfred-Nobel Blvd
Suite 300
Montreal, Canada H4S 0A4
Submission Control Number: 282989
®ISTODAX is a registered trademark of Celgene Corporation used under
license by Bristol-Myers
Squibb Canada.
Date of
Initial Authorization:
FEB 27, 2024
_ _
_ISTODAX (romidepsin) _
_Page 2 of 40_
WHAT IS A NOTICE OF COMPLIANCE WITH CONDITIONS (NOC/C)?
An NOC/c is a form of market approval granted to a product on the
basis of promising evidence of
clinical effectiveness following review of the submission by Health
Canada.
Products authorized under Health Canada’s NOC/c policy are intended
for the treatment,
prevention or diagnosis of a serious, life-threatening or severely
debilitating illness. They have
demonstrated promising benefit, are of high quality and possess an
acceptable safety profile based
on a benefit/risk assessment. In addition, they either respond to a
serious unmet medical need in
Canada or have demonstrated a significant improvement in the