Anpheros Search · Treatment

Thiotepa

Also known as: Tepadina · Thiotepa Riemser

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In short

In the European Union, thiotepa is indicated in combination with other chemotherapy medicinal products, with or without total body irradiation, as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation in haematological diseases in adult and paediatric patients. It is also indicated in the European Union when high dose chemotherapy with haematopoietic progenitor cell transplantation support is appropriate for treating solid tumours in adult and paediatric patients. In the United States, thiotepa is indicated to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor cell transplantation for pediatric patients with class 3 beta-thalassemia. Additionally, in the United States, it is indicated for the treatment of adenocarcinoma of the breast or ovary, for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities, and for the treatment of superficial papillary carcinoma of the urinary bladder.

From: Source: European Medicines Agency (EMA), Tepadina — EPAR, 24/02/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
10473 thiotepa
EMA
EMEA/H/C/001046, EMEA/H/C/005434

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Tepadina

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 solid tumours in adult and paediatric patients.

Source: European Medicines Agency (EMA), Tepadina — EPAR, 24/02/2026. © European Medicines Agency.

Document date: 24/02/2026 · Official document →

FDA (USA) TEPADINA

1 INDICATIONS AND USAGE TEPADINA (thiotepa) is an alkylating drug indicated: To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. (1.1 , 14) For treatment of adenocarcinoma of the breast or ovary. (1.2) For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. (1.3) For treatment of superficial papillary carcinoma of the urinary bladder. (1.4) 1.1 Class 3 Beta-Thalassemia TEPADINA is indicated to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia [see Clinical Studies ( 14 ) ] . 1.2 Adenocarcinoma of the Breast or Ovary TEPADINA is indicated for treatment of adenocarcinoma of the breast or ovary. 1.3 Malignant Effusions TEPADINA is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. 1.4 Superficial Papillary Carcinoma of the Urinary Bladder TEPADINA is indicated for treatment of superficial papillary carcinoma of the urinary bladder.

1.1 Class 3 Beta-Thalassemia TEPADINA is indicated to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia [see Clinical Studies ( 14 ) ] .

1.2 Adenocarcinoma of the Breast or Ovary TEPADINA is indicated for treatment of adenocarcinoma of the breast or ovary.

1.3 Malignant Effusions TEPADINA is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.

1.4 Superficial Papillary Carcinoma of the Urinary Bladder TEPADINA is indicated for treatment of superficial papillary carcinoma of the urinary bladder.

Data provided by the U.S. Food and Drug Administration.

Document date: 20260130 · Official document →

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Questions

What is Thiotepa approved for in the European Union?

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 solid tumours in adult and paediatric patients. (Source: European Medicines Agency (EMA), Tepadina — EPAR, 24/02/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Tepadina — EPAR, 24/02/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →