Pharmaceuticals - Union Register


Union Register of medicinal products for human use


Product information

Invented name: Tepadina   
Auth. number : EU/1/10/622
Active substance : Thiotepa
Orphan market exclusivity for "Conditioning treatment prior to haematopoietic progenitor cell transplantation" (based on designation EU/3/06/424) started on 17/03/2010
   10 years of market exclusivity
   This orphan market exclusivity will expire on 17/03/2020
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01A - Alkylating agents
Chemical subgroup: L01AC - Ethylene imines
Chemical substance: L01AC01 - thiotepa
(See WHO ATC Index)
Indication: Tepadina is indicated, 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.
Marketing Authorisation Holder: ADIENNE S.r.l.
Via Galileo Galilei 19, 20867 Caponago (MB), Italia
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
17/03/2010 Centralised - Authorisation EMEA/H/C/1046 (2010)1799 of 15/03/2010
27/05/2010 Centralised - Variation EMEA/H/C/1046/IA/1/G
Updated with Decision(2011)75 of 06/01/2011
11/01/2011 Centralised - Variation (2011)75 of 6/01/2011
23/03/2011 Centralised - Notification EMEA/H/C/1046/N/2
Updated with Decision(2011)6236 of 26/08/2011
31/08/2011 Centralised - Variation EMEA/H/C/1046/II/4/G (2011)6236 of 26/08/2011
27/01/2012 Centralised - Notification EMEA/H/C/1046/N/6
Updated with Decision(2014)2915 of 28/04/2014
20/11/2012 Corrigendum (2012)8482 of 29/10/2012
15/04/2013 Centralised - Variation EMEA/H/C/1046/IAIN/11/G
Updated with Decision(2014)2915 of 28/04/2014
25/04/2013 Centralised - Variation EMEA/H/C/1046/II/10/G
Updated with Decision(2014)2915 of 28/04/2014
18/10/2013 Centralised - Variation EMEA/H/C/1046/IAIN/13/G
Updated with Decision(2014)2915 of 28/04/2014
21/02/2014 Centralised - Variation EMEA/H/C/1046/IA/14
Updated with Decision(2014)2915 of 28/04/2014
30/04/2014 Centralised - Yearly update (2014)2915 of 28/04/2014
6/06/2014 Centralised - Notification EMEA/H/C/1046/N/16
Updated with Decision(2014)8722 of 17/11/2014
19/11/2014 Centralised - Renewal EMEA/H/C/1046/R/17 (2014)8722 of 17/11/2014
21/05/2015 Centralised - Variation EMEA/H/C/1046/II/18
Updated with Decision(2016)2992 of 12/05/2016
24/09/2015 Centralised - Variation EMEA/H/C/1046/II/21
Updated with Decision(2016)2992 of 12/05/2016
25/02/2016 Centralised - Variation EMEA/H/C/1046/II/26
Updated with Decision(2016)2992 of 12/05/2016
12/04/2016 Centralised - Notification EMEA/H/C/1046/N/27
Updated with Decision(2016)2992 of 12/05/2016
16/05/2016 Centralised - Yearly update (2016)2992 of 12/05/2016
15/08/2017 Centralised - Variation EMEA/H/C/1046/IB/29
Updated with Decision(2018)5378 of 02/08/2018
29/11/2017 Centralised - Variation EMEA/H/C/1046/IAIN/30/G
Updated with Decision(2018)5378 of 02/08/2018
6/08/2018 Centralised - Yearly update (2018)5378 of 2/08/2018