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.
Tepadina : EPAR - Summary for the public (PDF/87.78 KB)
First published: 06/05/2010
Last updated: 23/12/2014
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Hematopoietic Stem Cell Transplantation
|Anatomical therapeutic chemical (ATC) code||
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.
|Date of issue of marketing authorisation valid throughout the European Union||
29/11/2017 Tepadina - EMEA/H/C/001046 - IAIN/0030/G
- 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
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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.