Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Replagal   
Auth. number : EU/1/01/189
INN : Agalsidase alfa
Orphan status based on designation EU/3/00/002 added on 07/08/2001
Orphan status based on designation EU/3/00/002 removed or expired on 07/08/2011
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A16 - Other alimentary tract and metabolism products
Pharmacological subgroup: A16A - Other alimentary tract and metabolism products
Chemical subgroup: A16AB - Enzymes
Chemical substance: A16AB03 - Agalsidase alfa
(See WHO ATC Index)
Indication: Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency).
Marketing Authorisation Holder: Shire Human Genetic Therapies AB
Svärdvägen 11D, SE-182 33 Danderyd, Sverige

  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
07/08/2001 Centralised - Authorisation EMEA/H/C/369 (2001)2080 of 03/08/2001
07/01/2002 Centralised - Variation EMEA/H/C/369/I/2
07/02/2002 Centralised - Variation EMEA/H/C/369/I/3
05/03/2002 Centralised - Variation EMEA/H/C/369/I/1 (2001)938 of 28/02/2002
12/04/2002 Centralised - Variation EMEA/H/C/369/N/5 (2002)1439 of 10/04/2002
12/09/2002 Centralised - Variation EMEA/H/C/369/I/9 (2002)3382 of 10/09/2002
12/09/2002 Centralised - Variation EMEA/H/C/369/II/11
12/09/2002 Centralised - Variation EMEA/H/C/369/I/10 (2002)3383 of 10/09/2002
07/10/2002 Centralised - Variation EMEA/H/C/369/II/8 (2002)3711 of 03/10/2002
21/10/2002 Centralised - Variation EMEA/H/C/369/II/11
21/10/2002 Centralised - Variation EMEA/H/C/369/II/2
30/01/2003 Centralised - Annual reassessment EMEA/H/C/369/S/12 (2003)434 of 28/01/2003
07/02/2003 Centralised - Variation EMEA/H/C/369/I/14
19/02/2003 Centralised - Variation EMEA/H/C/369/I/13 (2003)612 of 17/02/2003
19/02/2003 Centralised - Variation EMEA/H/C/369/I/15 (2003)616 of 17/02/2003
31/03/2003 Centralised - Variation EMEA/H/C/369/II/21
01/04/2003 Centralised - Variation EMEA/H/C/369/I/16
24/07/2003 Centralised - Variation EMEA/H/C/269/II/17 (2003)2737 of 22/07/2003
08/10/2003 Centralised - Variation EMEA/H/C/369/II/18 (2003)3612 of 03/10/2003
20/01/2004 Centralised - Annual reassessment EMEA/H/C/369/S/19 (2004)117 of 16/01/2004
31/03/2004 Centralised - Variation EMEA/H/C/369/II/24
23/07/2004 Centralised - Variation EMEA/H/C/369/II/23 (2004)2899 of 20/07/2004
02/08/2004 Centralised - Variation EMEA/H/C/369/II/22 (2004)3006 of 29/07/2004
18/11/2004 Centralised - Variation EMEA/H/C/369/IA/26
Updated with Decision(2005)565 of 03/03/2005
07/03/2005 Centralised - Annual reassessment EMEA/H/C/369/S/25 (2005)565 of 03/03/2005
29/07/2005 Centralised - Variation EMEA/H/C/369/II/27 (2005)2967 of 27/07/2005
22/11/2005 Centralised - Variation EMEA/H/C/369/II/28
13/02/2006 Centralised - Annual reassessment EMEA/H/C/369/S/29 (2006)451 of 09/02/2006
03/07/2006 Centralised - Variation EMEA/H/C/369/II/31
01/08/2006 Centralised - Renewal EMEA/H/C/369/R/30 (2006)3493 of 28/07/2006
07/09/2006 Centralised - Variation EMEA/H/C/369/II/33, 34 (2006)4072 of 01/09/2006
13/09/2006 Centralised - Variation EMEA/H/C/369/IA/36
Updated with Decision(2006)5864 of 24/11/2006
28/11/2006 Centralised - Variation EMEA/H/C/369/II/35 (2006)5864 of 24/11/2006
14/02/2007 Centralised - Annual reassessment EMEA/H/C/369/S/37 (2007)509 of 12/02/2007
17/09/2007 Centralised - Variation EMEA/H/C/369/IA/42
Updated with Decision(2008)952 of 05/03/2008
24/10/2007 Centralised - Variation EMEA/H/C/369/II/41
21/12/2007 Centralised - Variation EMEA/H/C/369/II/44
07/03/2008 Centralised - Annual reassessment EMEA/H/C/369/S/43 (2008)952 of 05/03/2008
26/03/2008 Centralised - Variation EMEA/H/C/369/II/45
11/04/2008 Centralised - Variation EMEA/H/C/369/IA/46
21/10/2008 Centralised - Variation EMEA/H/C/369/IB/47
31/10/2008 Centralised - Variation EMEA/H/C/369/IA/49
Updated with Decision(2009)4353 of 29/05/2009
23/03/2009 Centralised - Variation EMEA/H/C/369/II/51
28/04/2009 Centralised - Variation EMEA/H/C/369/II/50
03/06/2009 Centralised - Variation (2009)4353 of 29/05/2009
25/06/2009 Centralised - Variation EMEA/H/C/369/IA/52
07/09/2009 Centralised - Variation EMEA/H/C/369/IA/53
28/12/2009 Centralised - Variation EMEA/H/C/369/II/54 (2009)10751 of 22/12/2009
23/03/2010 Centralised - Variation EMEA/H/C/369/IB/57
01/07/2010 Centralised - Variation EMEA/H/C/369/II/56
16/07/2010 Centralised - Variation EMEA/H/C/369/IA/59
Updated with Decision(2011)724 of 02/02/2011
30/09/2010 Centralised - Variation EMEA/H/C/369/II/58
08/12/2010 Centralised - Variation EMEA/H/C/369/N/29/G
07/01/2011 Centralised - Annual reassessment EMEA/H/C/369/S/60
04/02/2011 Centralised - Variation (2011)724 of 02/02/2011
28/03/2011 Centralised - Variation EMEA/H/C/369/IB/62
30/03/2011 Centralised - Variation EMEA/H/C/369/II/63/G
07/08/2011 Centralised - (orphan status)
03/01/2012 Centralised - Variation EMEA/H/C/369/IB/67
Updated with Decision(2012)1191 of 17/02/2012
22/02/2012 Centralised - Annual reassessment EMEA/H/C/369/S/68 (2012)1191 of 17/02/2012
04/06/2012 Centralised - Variation EMEA/H/C/369/IG/175/G
Updated with Decision(2012)6529 of 17/09/2012
19/09/2012 Centralised - Variation (2012)6529 of 17/09/2012
17/01/2013 Centralised - Variation EMEA/H/C/369/II/76
Updated with Decision(2013)4230 of 01/07/2013
03/07/2013 Centralised - Annual reassessment EMEA/H/C/369/S/75 (2013)4230 of 01/07/2013
14/08/2013 Centralised - Variation EMEA/H/C/369/IA/77
Updated with Decision(2014)2050 of 21/03/2014
21/11/2013 Centralised - Variation EMEA/H/C/369/II/78
Updated with Decision(2014)2050 of 21/03/2014
20/02/2014 Centralised - Variation EMEA/H/C/369/II/83
26/03/2014 Centralised - Annual reassessment EMEA/H/C/369/S/80 (2014)2050 of 21/03/2014
24/07/2014 Centralised - Variation EMEA/H/C/369/II/84/G