Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Yondelis   
Auth. number : EU/1/07/417
INN : Trabectedin
Orphan status based on designation EU/3/01/039 added on 20/09/2007
Orphan status based on designation EU/3/03/171 added on 30/10/2009
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01C - Plant alkaloids and other natural products
Chemical subgroup: L01CX - Other plant alkaloids and natural products
Chemical substance: L01CX01 - Trabectedin
(See WHO ATC Index)
Indication: Yondelis is indicated for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.

Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
Marketing Authorisation Holder: Pharma Mar S.A.
Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

  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 Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
20/09/2007 Centralised - Authorisation EMEA/H/C/773 (2007)4374 of 17/09/2007
05/03/2008 Centralised - Variation EMEA/H/C/773/IB/1
17/03/2008 Centralised - Variation EMEA/H/C/773/IB/2
Updated with Decision(2008)6056 of 13/10/2008
26/03/2008 Centralised - Variation EMEA/H/C/773/IA/3
19/05/2008 Centralised - Variation EMEA/H/C/773/IB/4
03/06/2008 Centralised - Variation EMEA/H/C/773/N/5
Updated with Decision(2008)6056 of 13/10/2008
15/10/2008 Centralised - Variation (2008)6056 of 13/10/2008
27/03/2009 Centralised - Variation EMEA/H/C/773/II/7 (2009)2312 of 25/03/2009
03/06/2009 Centralised - Variation EMEA/H/C/773/II/10
24/06/2009 Centralised - Annual reassessment EMEA/H/C/773/S/6 (2009)5126 of 22/06/2009
25/06/2009 Centralised - Variation EMEA/H/C/773/II/9 (2009)5149 of 23/06/2009
16/07/2009 Centralised - Variation EMEA/H/C/773/IB/11
30/10/2009 Centralised - Variation EMEA/H/C/773/II/8 (2009)8513 of 28/10/2009
22/02/2010 Centralised - Annual reassessment EMEA/H/C/773/S/12
03/06/2010 Centralised - Variation EMEA/H/C/773/IB/13
03/06/2010 Centralised - Variation EMEA/H/C/773/IB/14
24/06/2010 Centralised - Variation EMEA/H/C/773/IB/15
03/09/2010 Centralised - Variation EMEA/H/C/773/IA/16
26/10/2010 Centralised - Variation EMEA/H/C/773/IA/17
Updated with Decision(2011)3535 of 16/05/2011
19/11/2010 Centralised - Variation EMEA/H/C/773/IA/18
18/05/2011 Centralised - Annual reassessment EMEA/H/C/773/S/19 (2011)3535 of 16/05/2011
02/02/2012 Centralised - Variation EMEA/H/C/773/II/22/G (2012)655 of 31/01/2012
27/02/2012 Centralised - Annual reassessment EMEA/H/C/773/S/24
07/08/2012 Centralised - Renewal EMEA/H/C/773/R/25 (2012)5686 of 03/08/2012
13/12/2012 Centralised - Variation EMEA/H/C/773/II/28
Updated with Decision(2013)9758 of 18/12/2013
13/12/2012 Centralised - Variation EMEA/H/C/773/II/29
Updated with Decision(2013)9758 of 18/12/2013
22/03/2013 Centralised - Annual reassessment EMEA/H/C/773/S/33
27/06/2013 Centralised - Variation EMEA/H/C/773/II/34
Updated with Decision(2013)9758 of 18/12/2013
23/12/2013 Centralised - Variation (2013)9758 of 18/12/2013
06/03/2014 Centralised - Variation EMEA/H/C/773/IB/39
Updated with Decision(2014)3818 of 03/06/2014
05/06/2014 Centralised - Annual reassessment EMEA/H/C/773/S/37 (2014)3818 of 03/06/2014
25/06/2014 Centralised - Modification EMEA/H/C/773/PSUV/38 (2014)4366 of 23/06/2014