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HSA Product

TEPADINA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 15MG/VIAL

Product approved by Health Sciences Authority (SG)

Basic Information

TEPADINA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 15MG/VIAL

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Regulatory Information

SIN16553P

July 18, 2022

Prescription Only

Therapeutic

INTRAVENOUS

August 10, 2023

June 3, 2025

XL01AC01

Company Information

AXXESSBIO PTE. LTD.

AXXESSBIO PTE. LTD.

Active Ingredients

Thiotepa

Strength: 15mg/vial

Detailed Information

Contraindications

**4.3 Contraindications** Hypersensitivity to the active substance. Pregnancy and lactation (see section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

Indication Information

**4.1 Therapeutic indications** TEPADINA is indicated, in combination with other chemotherapy medicinal products: - with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; - when high dose chemotherapy with HPCT support is appropriate for the treatment of breast cancer in adult patients and CNS tumours in paediatric patients.

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