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.
This EPAR was last updated on 26/11/2020
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 | |
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Marketing-authorisation holder |
ADIENNE S.r.l. S.U.
|
Revision |
14
|
Date of issue of marketing authorisation valid throughout the European Union |
15/03/2010
|
Contact address |
Product information
03/11/2020 Tepadina - EMEA/H/C/001046 - IB/0038/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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
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.