Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Nplate   
Auth. number : EU/1/08/497
Active substance : romiplostim
Orphan market exclusivity for "Treatment of idiopathic thrombocytopenic purpura" (based on designation EU/3/05/283) started on 06/02/2009
   10 years of market exclusivity
   This orphan market exclusivity will expire on 06/02/2019
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: B02BX04 - Romiplostim
(See WHO ATC Index)
Indication: Nplate is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
Marketing Authorisation Holder: Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland
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
06/02/2009 Centralised - Authorisation EMEA/H/C/942 (2009)826 of 04/02/2009
06/02/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/942 (2009)825 of 04/02/2009
09/03/2009 Centralised - Variation EMEA/H/C/942/IB/1
Updated with Decision(2009)7844 of 08/10/2009
09/03/2009 Centralised - Variation EMEA/H/C/942/IB/2
Updated with Decision(2009)7844 of 08/10/2009
08/04/2009 Corrigendum (2009)826 cor of 03/04/2009
08/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/942/II/3
12/10/2009 Centralised - Variation (2009)7844 of 08/10/2009
08/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/942/II/9
13/01/2010 Centralised - Variation EMEA/H/C/942/X/4 (2010)96 of 11/01/2010
15/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/942/IB/11
27/08/2010 Centralised - Variation EMEA/H/C/942/IA/12/G
Updated with Decision(2010)8530 of 26/11/2010
20/10/2010 Centralised - Variation EMEA/H/C/942/IB/13
Updated with Decision(2010)8530 of 26/11/2010
15/11/2010 Centralised - Variation EMEA/H/C/942/IA/14/G
Updated with Decision(2011)727 of 02/02/2011
01/12/2010 Centralised - Variation EMEA/H/C/942/II/10/G (2010)8530 of 26/11/2010
04/02/2011 Centralised - Variation (2011)727 of 02/02/2011
02/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/942/IA/15
30/08/2011 Centralised - Variation EMEA/H/C/942/II/17 (2011)6160 of 24/08/2011
30/03/2012 Centralised - Variation EMEA/H/C/942/IB/21/G
Updated with Decision(2012)7613 of 23/10/2012
26/10/2012 Centralised - Variation EMEA/H/C/942/II/23 (2012)7613 of 23/10/2012
13/11/2012 Centralised - Variation EMEA/H/C/942/IB/28/G
Updated with Decision(2013)9837 of 20/12/2013
16/11/2012 Centralised - Variation EMEA/H/C/942/II/22
Updated with Decision(2013)9837 of 20/12/2013
14/02/2013 Centralised - Variation EMEA/H/C/942/IAin/32/G
Updated with Decision(2013)9837 of 20/12/2013
27/06/2013 Centralised - Variation EMEA/H/C/942/II/29
Updated with Decision(2013)9837 of 20/12/2013
24/12/2013 Centralised - Renewal EMEA/H/C/942/R/37 (2013)9837 of 20/12/2013
26/05/2014 Centralised - Notification EMEA/H/C/942/N/43
Updated with Decision(2015)8007 of 11/11/2015
20/11/2014 Centralised - Variation EMEA/H/C/942/II/45
Updated with Decision(2015)8007 of 11/11/2015
25/06/2015 Centralised - Variation EMEA/H/C/942/II/49
Updated with Decision(2015)8007 of 11/11/2015
13/11/2015 Centralised - Yearly update (2015)8007 of 11/11/2015
26/01/2016 Centralised - 2-Monthly update EMEA/H/C/942/II/51 (2016)409 of 22/01/2016
27/01/2016 Centralised - Variation EMEA/H/C/942/IB/54
Updated with Decision(2016)2541 of 21/04/2016
25/04/2016 PSUSA - Modification EMEA/H/C/942/PSUSA/2660/201507 (2016)2541 of 21/04/2016
09/06/2016 Centralised - Variation EMEA/H/C/942/IA/56/G
Updated with Decision(2017) 3957 of 02/06/2017
27/04/2017 Centralised - Variation EMEA/H/C/942/II/62/G
Updated with Decision(2017) 3957 of 02/06/2017
07/06/2017 Centralised - Yearly update (2017) 3957 of 02/06/2017