Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xagrid   
Auth. number : EU/1/04/295
INN : anagrelide
Orphan status based on designation EU/3/00/010 added on 18/11/2004
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX35 - Anagrelide
(See WHO ATC Index)
Indication: Xagrid is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.
An at risk patient
An at risk essential thrombocythaemia patient is defined by one or more of the following features:
• > 60 years of age or
• a platelet count > 1000 x 109/l or
• a history of thrombo-haemorrhagic events.
Marketing Authorisation Holder: Shire Pharmaceutical Contracts Ltd
Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, 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 continues to be 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
18/11/2004 Centralised - Authorisation EMEA/H/C/480 (2004)4462 of 16/11/2004
13/09/2005 Centralised - Variation EMEA/H/C/480/II/1 (2005)3487 of 08/09/2005
09/11/2005 Centralised - Variation EMEA/H/C/480/II/3 (2005)4390 of 07/11/2005
21/12/2005 Centralised - Variation EMEA/H/C/480/IA/5
02/03/2006 Centralised - Variation EMEA/H/C/480/II/4 (2006)695 of 28/02/2006
12/05/2006 Centralised - Variation EMEA/H/C/480/IA/10
12/05/2006 Centralised - Variation EMEA/H/C/480/IA/9
12/05/2006 Centralised - Variation EMEA/H/C/480/IA/8
23/05/2006 Centralised - Annual reassessment EMEA/H/C/480/S/6 (2006)2119 of 19/05/2006
09/08/2006 Centralised - Variation EMEA/H/C/480/II/7 (2006)3668 of 07/08/2006
28/09/2006 Centralised - Variation EMEA/H/C/480/N/11
Updated with Decision(2007)1510 of 28/03/2007
30/03/2007 Centralised - Variation EMEA/H/C/480/II/12 (2007)1510 of 28/03/2007
14/05/2007 Centralised - Annual reassessment EMEA/H/C/480/S/13 (2007)2195 of 15/05/2007
14/05/2007 Centralised - Variation EMEA/H/C/480/IA/14
20/06/2007 Centralised - Variation EMEA/H/C/480/IA/17
20/06/2007 Centralised - Variation EMEA/H/C/480/IA/16
20/06/2007 Centralised - Variation EMEA/H/C/480/IA/15
20/06/2007 Centralised - Variation EMEA/H/C/480/IA/18
29/01/2008 Centralised - Variation EMEA/H/C/480/II/19 (2008)386 of 25/01/2008
30/04/2008 Centralised - Variation EMEA/H/C/480/II/21
23/05/2008 Centralised - Annual reassessment EMEA/H/C/480/S/20 (2008)2184 of 21/05/2008
01/09/2008 Centralised - Variation EMEA/H/C/480/N/25
Updated with Decision(2008)7604 of 25/11/2008
22/10/2008 Centralised - Variation EMEA/H/C/480/IA/27
27/11/2008 Centralised - Variation EMEA/H/C/480/II/26 (2008)7604 of 25/11/2008
02/03/2009 Centralised - Variation EMEA/H/C/480/II/28 (2009)1462 of 26/02/2009
05/05/2009 Centralised - Annual reassessment EMEA/H/C/480/S/29 (2009)3574 of 30/04/2009
04/11/2009 Centralised - Renewal EMEA/H/C/480/R/30 (2009)8606 of 30/10/2009
07/01/2010 Centralised - Variation EMEA/H/C/480/N/31
Updated with Decision(2010)2181 of 26/03/2010
29/03/2010 Centralised - Variation EMEA/H/C/480/II/32 (2010)2181 of 26/03/2010
06/05/2010 Centralised - Variation EMEA/H/C/480/IB/34
Updated with Decision(2010)8526 of 26/11/2010
28/05/2010 Centralised - Annual reassessment EMEA/H/C/480/S/33 (2010)3491 of 26/05/2010
22/06/2010 Centralised - Variation EMEA/H/C/480/IA/35/G
22/10/2010 Centralised - Variation EMEA/H/C/480/IA/39/G
28/10/2010 Centralised - Variation EMEA/H/C/480/IA/40/G
28/10/2010 Centralised - Variation EMEA/H/C/480/IB/38
28/10/2010 Centralised - Variation EMEA/H/C/480/IA/41
22/11/2010 Centralised - Variation EMEA/H/C/480/IB/42
01/12/2010 Centralised - Variation EMEA/H/C/480/II/36 (2010)8526 of 26/11/2010
14/12/2010 Centralised - Variation EMEA/H/C/480/IB/37/G
23/02/2011 Centralised - Variation EMEA/H/C/480/IB/44
25/02/2011 Centralised - Variation EMEA/H/C/480/IA/45/G
Updated with Decision(2011)7174 of 03/10/2011
12/05/2011 Centralised - Annual reassessment EMEA/H/C/480/S/43 (2011)3231 of 06/05/2011
06/06/2011 Centralised - Variation EMEA/H/C/480/N/46
Updated with Decision(2011)7174 of 03/10/2011
05/10/2011 Centralised - Variation (2011)7174 of 03/10/2011
17/01/2013 Centralised - Annual reassessment EMEA/H/C/480/S/48 (2013)217 of 14/01/2013
22/05/2013 Centralised - Annual reassessment EMEA/H/C/480/S/53 (2013)2986 of 16/05/2013
21/11/2013 Centralised - Variation EMEA/H/C/480/II/56
30/01/2014 Centralised - Variation EMEA/H/C/480/IA/58/G
20/03/2014 Centralised - Annual reassessment EMEA/H/C/480/S/57