Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Revolade   
Auth. number : EU/1/10/612
INN : Eltrombopag
Orphan status based on designation EU/3/07/467 added on 15/03/2010
Orphan status based on designation EU/3/07/467 removed or expired on 09/12/2011
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B02 - Antihemorrhagics
Pharmacological subgroup: B02B - Vitamin K and other hemostatics
Chemical subgroup: B02BX - Other systemic hemostatics
Chemical substance: B02BX05 - Eltrombopag
(See WHO ATC Index)
Indication: Revolade is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Revolade may be considered as second line treatment for adult non-splenectomised patients where surgery is contraindicated.
Marketing Authorisation Holder: GlaxoSmithKline Trading Services Limited
Currabinny, Carrigaline, County Cork, Ireland

  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
12/03/2010 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1110 (2010)1661 of 11/03/2010
15/03/2010 Centralised - Authorisation EMEA/H/C/1110 (2010)1662 of 11/03/2010
02/09/2010 Centralised - Variation EMEA/H/C/1110/IB/2
02/09/2010 Centralised - Variation EMEA/H/C/1110/IB/3
02/09/2010 Centralised - Variation EMEA/H/C/1110/IB/4
02/09/2010 Centralised - Variation EMEA/H/C/1110/IB/1
19/01/2011 Centralised - Variation EMEA/H/C/1110/IG/34/G
Updated with Decision(2011)3087 of 02/05/2011
09/02/2011 Centralised - Variation EMEA/H/C/1110/IB/7/G
23/03/2011 Centralised - Variation EMEA/H/C/1110/IB/6/G
03/05/2011 Centralised - Variation EMEA/H/C/1110/II/5 (2011)3088 of 02/05/2011
04/05/2011 Centralised - Variation EMEA/H/C/1110/II/5 (2011)3087 of 02/05/2011
22/09/2011 Centralised - Variation EMEA/H/C/1110/IA/8/G
Updated with Decision(2012)2975 of 26/04/2012
09/12/2011 Centralised - (orphan status)
30/04/2012 Centralised - Variation (2012)2975 of 26/04/2012
02/07/2012 Centralised - Variation EMEA/H/C/1110/II/10 (2012)4495 of 27/06/2012
23/09/2013 Centralised - Variation EMEA/H/C/1110/X/12/G (2013)6211 of 19/09/2013
22/05/2014 Centralised - Variation EMEA/H/C/1110/II/15/G
05/06/2014 Centralised - Variation EMEA/H/C/1110/IG/442