Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Nplate   
Auth. number : EU/1/08/497
INN : romiplostim
Orphan status based on designation EU/3/05/283 added on 06/02/2009
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) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
Nplate may be considered as second line treatment for adult non-splenectomised patients where surgery is contra-indicated.
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 corr 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
20/11/2014 Centralised - Variation EMEA/H/C/942/II/45