Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
THIOTEPA
STERIMAX INC
L01AC01
THIOTEPA
15MG
POWDER FOR SOLUTION
THIOTEPA 15MG
INTRAVENOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0107649001; AHFS:
APPROVED
2022-05-18
_Thiotepa for Injection USP _ _Page 1 of 46 _ “Thiotepa for Injection USP 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 USP 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 USP are being carried out by the manufacturer of the Canadian Reference Product.” PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR THIOTEPA FOR INJECTION USP Lyophilised powder for solution upon reconstitution and dilution, 15 mg / vial and 100 mg / vial, intravenous USP Antineoplastic Agent ATC code: L01AC01 SteriMax Inc. 2770 Portland Drive Oakville, ON, Canada L6H 6R4 Submission Control Number: 272936 Date of Initial Authorization: May 18, 2022 Date of Revision: October 4, 2023 _Thiotepa for Injection USP _ _Page 2 of 46 _ RECENT MAJOR LABEL CHANGES Not Applicable TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 5 1 INDICATIONS ............................................................................................................... 5 1.1 Pediatrics .. Belgenin tamamını okuyun