Thiotepa Riemser

thiotepa

Overview
Authorisation details
Product information
Assessment history

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.

: Thiotepa Riemser can only be obtained with a prescription. The medicine must be given under the supervision of a doctor who has experience in conditioning treatments given before transplantation.
Thiotepa Riemser is given by infusion (drip) into a large vein over 2 to 4 hours. The dose depends on the type of blood disease or tumour that the patient has and the type of transplantation to be carried out as well as the patient’s weight or weight and height.
For more information about using Thiotepa Riemser, see the package leaflet or contact your doctor or pharmacist.

: The active substance in Thiotepa Riemser, thiotepa, belongs to a group of medicines called ‘alkylating agents’. These substances are ‘cytotoxic’. This means that they kill cells, especially cells that multiply rapidly, such as cancer of progenitor (or ‘stem’) cells (cells that can develop into different types of cell).
Thiotepa Riemser is used with other medicines before transplantation to destroy the abnormal cells and the patient’s existing blood-making cells. This allows new cells to be transplanted, by creating space for the new cells and reducing the risk of rejection. Thiotepa has been used to prepare patients for transplantation of blood-making cells in the European Union (EU) since the late 1980s.

: The company provided data from the published literature on thiotepa. Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Tepadina, and do not need to be repeated for Thiotepa Riemser.
As for every medicine, the company provided studies on the quality of Thiotepa Riemser. There was no need for ‘bioequivalence’ studies to investigate whether Thiotepa Riemser is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Thiotepa Riemser is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

: Because Thiotepa Riemser is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

: The European Medicines Agency concluded that, in accordance with EU requirements, Thiotepa Riemser has been shown to be comparable to Tepadina. Therefore, the Agency’s view was that, as for Tepadina, the benefits of Thiotepa Riemser outweigh the identified risks and it can be authorised for use in the EU.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thiotepa Riemser have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Thiotepa Riemser are continuously monitored. Side effects reported with Thiotepa Riemser are carefully evaluated and any necessary action taken to protect patients.

: Thiotepa Riemser received a marketing authorisation valid throughout the EU on 26 March 2021.

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Thiotepa Riemser : EPAR - Medicine overview (PDF/133.5 KB)

First published: 30/04/2021
EMA/94265/2021
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Thiotepa Riemser : EPAR - Risk-management-plan summary (PDF/130.04 KB)

First published: 30/04/2021

This EPAR was last updated on 16/02/2023

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
Generic	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	3
Date of issue of marketing authorisation valid throughout the European Union	26/03/2021
Contact address	Hohenzollerndamm 150-151 14199 Berlin Germany

Product information

15/02/2023 Thiotepa Riemser - EMEA/H/C/005434 - IB/0005

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Thiotepa Riemser : EPAR - Product information (PDF/296.28 KB)

First published: 30/04/2021
Last updated: 16/02/2023
- Bulgarian
  (PDF/385.56 KB)
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  (PDF/336.17 KB)
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  (PDF/351.57 KB)
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  (PDF/372.56 KB)
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  (PDF/345.26 KB)
- Slovenian
  (PDF/334.6 KB)
- Spanish
  (PDF/259.27 KB)
- Swedish
  (PDF/255.91 KB)

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

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.

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Thiotepa Riemser : EPAR - All authorised presentations (PDF/14.34 KB)

First published: 30/04/2021
- Bulgarian
  (PDF/41.02 KB)
- Croatian
  (PDF/34.28 KB)
- Czech
  (PDF/33.74 KB)
- Danish
  (PDF/12.94 KB)
- Dutch
  (PDF/12.83 KB)
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  (PDF/14.98 KB)
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  (PDF/39.06 KB)
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- Icelandic
  (PDF/13.97 KB)
- Italian
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- Latvian
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- Lithuanian
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- Maltese
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- Norwegian
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- Polish
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- Portuguese
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- Romanian
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- Slovak
  (PDF/32.56 KB)
- Slovenian
  (PDF/21.09 KB)
- Spanish
  (PDF/13.09 KB)
- Swedish
  (PDF/12.98 KB)

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

Changes since initial authorisation of medicine

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Thiotepa Riemser : EPAR - Procedural steps taken and scientific information after the authorisation (PDF/141.4 KB)

First published: 10/08/2021
Last updated: 16/02/2023

Initial marketing-authorisation documents

News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 2021

29/01/2021

Thiotepa Riemser

Table of contents

Overview