Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pixuvri   
Auth. number : EU/1/12/764
INN : pixantrone
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01D - Cytotoxic antibiotics
Chemical subgroup: L01DB - Anthracyclines
Chemical substance: L01DB11 - Pixantrone
(See WHO ATC Index)
Indication: Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.
Marketing Authorisation Holder: CTI Life Sciences Ltd
Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

  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
14/05/2012 Centralised - Authorisation EMEA/H/C/2055 (2012)3219 of 10/05/2012
11/07/2012 Centralised - Variation EMEA/H/C/2055/IB/3
Updated with Decision(2012)7922 of 29/10/2012
06/11/2012 Centralised - Variation (2012)7922 of 29/10/2012
26/03/2013 Centralised - Annual renewal EMEA/H/C/2055/R/5 (2013)1846 of 22/03/2013
14/06/2013 Centralised - Variation EMEA/H/C/2055/IAin/7/G
Updated with Decision(2014)2594 of 10/04/2014
01/07/2013 Centralised - Variation EMEA/H/C/2055/IB/6
Updated with Decision(2014)2594 of 10/04/2014
14/08/2013 Centralised - Modification EMEA/H/C/2055/PSU/3 (2013)5446 of 12/08/2013
01/10/2013 Centralised - Variation EMEA/H/C/2055/IB/9
Updated with Decision(2014)2594 of 10/04/2014
16/12/2013 Centralised - Variation EMEA/H/C/2055/IAin/13
Updated with Decision(2014)2594 of 10/04/2014
14/04/2014 Centralised - Annual renewal EMEA/H/C/2055/R/14 (2014)2594 of 10/04/2014
12/06/2014 Centralised - Variation EMEA/H/C/2055/IB/16
Updated with Decision(2014)6279 of 01/09/2014
03/09/2014 Centralised - Modification EMEA/H/C/2055/PSUV/15 (2014)6279 of 01/09/2014
20/10/2014 Centralised - Notification EMEA/H/C/2055/N/19