Country: Канада
Језик: Енглески
Извор: Health Canada
THIOTEPA
ADIENNE SA
L01AC01
THIOTEPA
100MG
POWDER FOR SOLUTION
THIOTEPA 100MG
INTRAVENOUS
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0107649002; AHFS:
APPROVED
2017-03-29
_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 Прочитајте комплетан документ