Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ferriprox   
Auth. number : EU/1/99/108
INN : Deferiprone
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V03 - All other therapeutic products
Pharmacological subgroup: V03A - All other therapeutic products
Chemical subgroup: V03AC - Iron chelating agents
Chemical substance: V03AC02 - Deferiprone
(See WHO ATC Index)
Indication: Ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.
Marketing Authorisation Holder: Apotex Europe B.V.
Darwinweg 20, NL- 2333 CR Leiden, 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
02/09/1999 Centralised - Authorisation EMEA/H/C/236 (1999)2820 of 25/08/1999
28/02/2000 Centralised - Variation EMEA/H/C/236/I/1 (2000)424 of 22/02/2000
22/11/2000 Centralised - Variation EMEA/H/C/236/I/3
22/11/2000 Centralised - Variation EMEA/H/C/236/I/4
02/12/2000 Centralised - Variation EMEA/H/C/236/N/2 (2000)3423 of 01/12/2000
08/03/2001 Centralised - Variation EMEA/H/C/236/N/6 (2001)317 of 06/03/2001
07/02/2002 Centralised - Annual reassessment EMEA/H/C/236/S/5 (2002)476 of 05/02/2002
16/04/2002 Centralised - Annual reassessment EMEA/H/C/236/S/9 (2002)1487 of 12/04/2002
28/06/2002 Centralised - Variation EMEA/H/C/236/I/10
31/03/2003 Centralised - Variation EMEA/H/C/236/I/11
15/04/2003 Centralised - Variation EMEA/H/C/236/I/12 (2003)1267 of 10/04/2003
28/04/2003 Centralised - Variation EMEA/H/C/236/I/14
28/04/2003 Centralised - Variation EMEA/H/C/236/I/13
14/05/2003 Centralised - Variation EMEA/H/C/236/N/15 (2003)1619 of 12/05/2003
07/10/2003 Centralised - Variation EMEA/H/C/236/II/16 (2003)3616 of 03/10/2003
29/01/2004 Centralised - Variation EMEA/H/C/236/IA/20
29/01/2004 Centralised - Variation EMEA/H/C/236/IA/19
03/02/2004 Centralised - Variation EMEA/H/C/236/IB/18
10/03/2004 Centralised - Variation EMEA/H/C/236/IA/21
31/03/2004 Centralised - Variation EMEA/H/C/236/IA/25
31/03/2004 Centralised - Variation EMEA/H/C/236/IA/24
11/05/2004 Centralised - Variation EMEA/H/C/236/II/17 (2004)1826 of 07/05/2004
09/06/2004 Centralised - Variation EMEA/H/C/236/II/23
06/09/2004 Centralised - Renewal EMEA/H/C/230/R/26 (2004)3421 of 02/09/2004
21/10/2004 Centralised - Variation EMEA/H/C/236/IA/28
21/10/2004 Centralised - Variation EMEA/H/C/236/IA/27
08/11/2004 Centralised - Variation EMEA/H/C/236/IA/29
06/12/2004 Centralised - Variation EMEA/H/C/236/IB/30
23/12/2004 Centralised - Variation EMEA/H/C/236/IB/31
Updated with Decision(2005)3264 of 22/08/2005
23/03/2005 Centralised - Variation EMEA/H/C/236/II/32
26/07/2005 Centralised - Variation EMEA/H/C/236/IA/33
24/08/2005 Centralised - Variation EMEA/H/C/236 (2005)3264 of 22/08/2005
06/02/2006 Centralised - Variation EMEA/H/C/236/II/34 (2006)291 of 30/01/2006
13/03/2006 Centralised - Variation EMEA/H/C/236/IA/35
17/03/2006 Centralised - Variation EMEA/H/C/236/N/37
Updated with Decision(2007)309 of 26/01/2007
10/08/2006 Centralised - Variation EMEA/H/C/236/IA/38
02/02/2007 Centralised - Variation EMEA/H/C/236/N/40
Updated with Decision(2007)3250 of 29/06/2007
08/02/2007 Centralised - Variation EMEA/H/C/236/IA/41
28/02/2007 Centralised - Variation EMEA/H/C/236/II/39 (2007)309 of 26/01/2007
03/07/2007 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/236/T/42 (2007)3250 of 29/06/2007
21/11/2007 Centralised - Variation EMEA/H/C/236/X/36 (2007)5663 of 19/11/2007
29/11/2007 Centralised - Variation EMEA/H/C/236/IB/44
25/04/2008 Centralised - Variation EMEA/H/C/236/II/43 (2008)1704 of 23/04/2008
30/04/2008 Centralised - Variation EMEA/H/C/236/IB/45
04/07/2008 Centralised - Variation EMEA/H/C/236/IB/46
04/07/2008 Centralised - Variation EMEA/H/C/236/IA/48
08/07/2008 Centralised - Variation EMEA/H/C/236/IB/47
27/08/2008 Centralised - Variation EMEA/H/C/236/IA/49
23/10/2008 Centralised - Variation EMEA/H/C/236/IA/50
Updated with Decision(2009)4404 of 02/06/2009
24/02/2009 Centralised - Variation EMEA/H/C/236/N/51
Updated with Decision(2009)4404 of 02/06/2009
11/03/2009 Centralised - Variation EMEA/H/C/236/IA/55
13/03/2009 Centralised - Variation EMEA/H/C/236/IA/56
25/03/2009 Centralised - Variation EMEA/H/C/236/II/53
04/06/2009 Centralised - Variation (2009)4404 of 02/06/2009
26/06/2009 Centralised - Variation EMEA/H/C/236/N/57
Updated with Decision(2009)7414 of 21/09/2009
23/09/2009 Centralised - Renewal EMEA/H/C/236/R/54 (2009)7414 of 21/09/2009
03/12/2009 Centralised - Variation EMEA/H/C/236/IA/59
26/02/2010 Centralised - Variation EMEA/H/C/236/IB/60
04/05/2010 Centralised - Variation EMEA/H/C/236/II/61/G
08/07/2010 Centralised - Variation EMEA/H/C/236/II/62 (2010)4788 of 05/07/2010
30/07/2010 Centralised - Variation EMEA/H/C/236/X/58 (2010)5401 of 28/07/2010
10/08/2010 Centralised - Variation EMEA/H/C/236/II/63 (2010)5603 of 06/08/2010
04/10/2010 Centralised - Variation EMEA/H/C/236/N/64
30/11/2010 Centralised - Variation EMEA/H/C/236/IA/66
14/12/2010 Centralised - Variation EMEA/H/C/236/IA/65/G
04/02/2011 Centralised - Variation EMEA/H/C/236/IA/67
04/02/2011 Centralised - Variation EMEA/H/C/236/IA/68
30/08/2011 Centralised - Variation EMEA/H/C/236/N/70
Updated with Decision(2012)7751 of 25/10/2012
21/03/2012 Centralised - Variation EMEA/H/C/236/IB/77
Updated with Decision(2012)7751 of 25/10/2012
30/03/2012 Centralised - Variation EMEA/H/C/236/N/76
Updated with Decision(2012)7751 of 25/10/2012
01/05/2012 Centralised - Variation EMEA/H/C/236/IB/79
Updated with Decision(2012)7751 of 25/10/2012
12/11/2012 Centralised - Variation (2012)7751 of 25/10/2012
25/04/2013 Centralised - Variation EMEA/H/C/236/II/84
Updated with Decision(2014)2805 of 23/04/2014
25/04/2014 Centralised - Variation (2014)2805 of 23/04/2014