Thiotepa Riemser

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thiotepa

Authorised
This medicine is authorised for use in the European Union.

Overview

Thiotepa Riemser is used in combination with chemotherapy in two ways:

  • as a ‘conditioning’ (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells). This type of transplant is used in patients who need replacement blood-making cells because they have a blood disease such as a cancer of the blood (e.g. leukaemia) or diseases causing low red-blood cell counts (including thalassaemia or sickle-cell anaemia);
  • during the treatment of solid tumours when high-dose chemotherapy followed by transplantation of haematopoietic progenitor cells is needed.

Thiotepa Riemser can be used for transplantation of progenitor cells from a donor or for transplantation of progenitor cells from the patient’s own body.

Thiotepa Riemser contains the active substance thiotepa and is a ‘generic medicine’. This means that Thiotepa Riemser contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Tepadina. For more information on generic medicines, see the question-and-answer document below.

This EPAR was last updated on 10/08/2021

Authorisation details

Product details
Name
Thiotepa Riemser
Agency product number
EMEA/H/C/005434
Active substance
thiotepa
International non-proprietary name (INN) or common name
thiotepa
Therapeutic area (MeSH)
  • Hematopoietic Stem Cell Transplantation
  • Neoplasms
Anatomical therapeutic chemical (ATC) code
L01AC01
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Esteve Pharmaceuticals GmbH
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
26/03/2021
Contact address

Hohenzollerndamm 150-151
14199 Berlin
Germany

Product information

01/12/2021 Thiotepa Riemser - EMEA/H/C/005434 - IAIN/0003/G

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Thiotepa Riemser 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.

Thiotepa Riemser 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

Assessment history

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