Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Javlor   
Auth. number : EU/1/09/550
INN : vinflunine ditartrate
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01C - Plant alkaloids and other natural products
Chemical subgroup: L01CA - Vinca alkaloids and analogues
Chemical substance: L01CA05 - Vinflunine
(See WHO ATC Index)
Indication: Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen
Efficacy and safety of vinflunine have not been studied in patients with performance status >= 2.
Marketing Authorisation Holder: Pierre Fabre Médicament
45, place Abel Gance, F-92100 Boulogne, France

  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
23/09/2009 Centralised - Authorisation EMEA/H/C/983 (2009)7421 of 21/09/2009
03/08/2010 Centralised - Variation EMEA/H/C/983/IB/3
23/12/2010 Centralised - Variation EMEA/H/C/983/II/1, 2 (2010)9634 of 20/12/2010
15/11/2011 Centralised - Variation EMEA/H/C/983/II/4/G, EMEA/H/C/983/II/6 (2011)8254 of 10/11/2011
26/06/2012 Centralised - Variation EMEA/H/C/983/IB/8
Updated with Decision(2012)7874 of 29/10/2012
02/07/2012 Centralised - Variation EMEA/H/C/983/II/7/G (2012)4505 of 27/06/2012
31/10/2012 Centralised - Variation (2012)7874 of 29/10/2012
25/06/2013 Centralised - Modification EMEA/H/C/983/PSUR/14 (2013)4021 of 21/06/2013
08/11/2013 Centralised - Variation EMEA/H/C/983/N/12
Updated with Decision(2014)3412 of 16/05/2014
20/05/2014 Centralised - Renewal (2014)3412 of 16/05/2014
23/06/2014 Centralised - Modification EMEA/H/C/983/PSUV/15 (2014)4278 of 19/06/2014