Land: Canada
Språk: engelsk
Kilde: Health Canada
THIOTEPA
HIKMA CANADA LIMITED
L01AC01
THIOTEPA
100MG
POWDER FOR SOLUTION
THIOTEPA 100MG
INTRAVENOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0107649002; AHFS:
APPROVED
2023-04-26
_ _ _ _ _THIOTEPA FOR INJECTION, BP _ _ _ _ Page 1 of 45_ _ _ 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 _ _ _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 Les hele dokumentet