Table of contents
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
Tepadina : EPAR - Risk management plan summary (PDF/125.82 KB)
First published: 07/09/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Hematopoietic Stem Cell Transplantation
|Anatomical therapeutic chemical (ATC) code||
ADIENNE S.r.l. S.U.
|Date of issue of marketing authorisation valid throughout the European Union||
Via Galileo Galilei, 19
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.
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.