TEPADINA POWDER FOR SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

THIOTEPA

Prieinama:

ADIENNE SA

ATC kodas:

L01AC01

INN (Tarptautinis Pavadinimas):

THIOTEPA

Dozė:

15MG

Vaisto forma:

POWDER FOR SOLUTION

Sudėtis:

THIOTEPA 15MG

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

15G/50G

Recepto tipas:

Prescription

Gydymo sritis:

ANTINEOPLASTIC AGENTS

Produkto santrauka:

Active ingredient group (AIG) number: 0107649001; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2017-03-29

Prekės savybės

_TEPADINA_
_®_
_ (thiotepa)_
_ _
_Page 1 of 52_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
TEPADINA
®
Thiotepa for Injection, BP
Lyophilised powder for infusion upon reconstitution and dilution, 15
mg or 100 mg,
intravenous
Lyophilised powder, 400 mg thiotepa/bag with solvent for
reconstitution, intravenous infusion
Antineoplastic Agent
ATC code: L01AC01
ADIENNE SA
Via Zurigo 46-6900
Lugano – Switzerland
Submission Control Number: 252188
Date of Initial Authorization:
March 29, 2017
Date of Revision:
December 29, 2021
“TEPADINA
®
, indicated for:
_- in combination with other chemotherapeutic products as part of a
high-dose chemotherapy _
_(HDCT) consolidation regimen followed by autologous stem cell
transplantation (ASCT) for _
_adult patients with central nervous system (CNS) lymphoma _
_ _
has been issued marketing authorization with conditions, pending the
results of trials to verify
its clinical benefit. Patients should be advised of the nature of the
authorization. For further
information for TEPADINA
®
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”
Pr
_TEPADINA_
_®_
_ (thiotepa)_
_ _
_Page 2 of 52_
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 benefit/risk profile
over exi