TEPADINA POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

THIOTEPA

Available from:

ADIENNE SA

ATC code:

L01AC01

INN (International Name):

THIOTEPA

Dosage:

100MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

THIOTEPA 100MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0107649002; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-03-29

Summary of Product characteristics

_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