Tepadina
thiotepa
Table of contents
Overview
This is a summary of the European Public Assessment Report (EPAR) for Tepadina. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tepadina.
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List item
Tepadina : EPAR - Summary for the public (PDF/87.78 KB)
First published: 06/05/2010
Last updated: 23/12/2014 -
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Tepadina : EPAR - Risk management plan summary (PDF/125.82 KB)
First published: 07/09/2022
Authorisation details
Product details | |
---|---|
Name |
Tepadina
|
Agency product number |
EMEA/H/C/001046
|
Active substance |
thiotepa
|
International non-proprietary name (INN) or common name |
thiotepa
|
Therapeutic area (MeSH) |
Hematopoietic Stem Cell Transplantation
|
Anatomical therapeutic chemical (ATC) code |
L01AC01
|
Publication details | |
---|---|
Marketing-authorisation holder |
ADIENNE S.r.l. S.U.
|
Revision |
18
|
Date of issue of marketing authorisation valid throughout the European Union |
15/03/2010
|
Contact address |
Via Galileo Galilei, 19 |
Product information
05/01/2022 Tepadina - EMEA/H/C/001046 - IB/0044
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.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
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.". It is proposed that Tepadina must be prescribed by physicians experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.