Tepadina

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thiotepa

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

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.

This EPAR was last updated on 25/01/2018

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
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Adienne S.r.l.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
15/03/2010
Contact address
Via Galileo Galilei, 19
20867 Caponago (MB)
Italy

Product information

29/11/2017 Tepadina - EMEA/H/C/001046 - IAIN/0030/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

L01 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.

Assessment history

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