THIOTEPA FOR INJECTION, BP POWDER FOR SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

THIOTEPA

Fáanlegur frá:

HIKMA CANADA LIMITED

ATC númer:

L01AC01

INN (Alþjóðlegt nafn):

THIOTEPA

Skammtar:

100MG

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

THIOTEPA 100MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2023-04-26

Vara einkenni

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_THIOTEPA FOR INJECTION, BP _
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_ Page 1 of 45_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
THIOTEPA FOR INJECTION, BP
Lyophilised powder for infusion upon reconstitution and dilution,
15 mg or 100 mg, intravenous
BP
Antineoplastic Agent
ATC code: L01AC01
“THIOTEPA FOR INJECTION, BP is indicated:
_- 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 _
and has been issued marketing authorization with conditions. Patients
should be advised of the
nature of the authorization. For further information for THIOTEPA FOR
INJECTION, BP 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. Note that trials to verify the clinical
benefit of the medicinal ingredient
in THIOTEPA FOR INJECTION, BP are being carried out by the
manufacturer of the Canadian
Reference Product.
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, ON Canada L5R 3P9
Date of Initial Authorization:
March 14, 2023
Submission Control Number: 256254
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_THIOTEPA FOR INJECTION, BP _
_Page 2 of 45_
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
improv