Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Elaprase   
Auth. number : EU/1/06/365
Active substance : Idursulfase
Orphan market exclusivity for "Treatment of Mucopolysaccharidosis, type II (Hunter Syndrome)" (based on designation EU/3/01/078) started on 10/01/2007
   10 years of market exclusivity
   This orphan market exclusivity will expire on 10/01/2017
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: A16AB09 - Idursulfase
(See WHO ATC Index)
Indication: Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
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
10/01/2007 Centralised - Authorisation EMEA/H/C/700 (2007)70 of 08/01/2007
24/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/II/2
18/10/2007 Centralised - Variation EMEA/H/C/700/II/1 (2007)5151 of 15/10/2007
29/11/2007 Centralised - Variation EMEA/H/C/700/IA/6
Updated with Decision(2008)3291 of 25/06/2008
11/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/IA/10
11/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/IA/11
11/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/IA/9
30/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/II/7
27/06/2008 Centralised - Variation (2008)3291 of 25/06/2008
04/09/2008 Centralised - Annual reassessment EMEA/H/C/700/S/8 (2008)4949 of 02/09/2008
30/10/2008 Centralised - Variation EMEA/H/C/700/IA/14
Updated with Decision(2009)827 of 04/02/2009
28/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/II/12
06/02/2009 Centralised - Variation EMEA/H/C/700/II/13 (2009)827 of 04/02/2009
25/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/II/6
05/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/II/15
27/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/IA/20
05/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/II/17
16/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/II/18
07/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/IA/21
23/09/2009 Centralised - Annual reassessment EMEA/H/C/700/S/19 (2009)7412 of 21/09/2009
12/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/II/25
25/01/2010 Centralised - Variation EMEA/H/C/700/II/22, 23, 24 (2010)372 of 20/01/2010
17/03/2010 Centralised - Variation EMEA/H/C/700/II/26 (2010)1766 of 15/03/2010
18/06/2010 Centralised - Variation EMEA/H/C/700/IA/29
Updated with Decision(2011)1154 of 18/02/2011
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/II/28
29/06/2010 Centralised - Annual reassessment EMEA/H/C/700/S/27
02/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/IG/29
22/02/2011 Centralised - Variation (2011)1154 of 18/02/2011
24/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/II/30
23/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/700/IB/31
05/10/2011 Centralised - Renewal EMEA/H/C/700/R/32 (2011)7178 of 03/10/2011
04/06/2012 Centralised - Variation EMEA/H/C/700/IG/175/G
Updated with Decision(2012)6848 of 24/09/2012
26/09/2012 Centralised - Variation (2012)6848 of 24/09/2012
15/11/2012 Centralised - Annual reassessment EMEA/H/C/700/S/36
16/11/2012 Centralised - Variation EMEA/H/C/700/II/35
Updated with Decision(2013)6212 of 19/09/2013
17/01/2013 Centralised - Variation EMEA/H/C/700/II/40
Updated with Decision(2013)6212 of 19/09/2013
23/09/2013 Centralised - Annual reassessment EMEA/H/C/700/S/44 (2013)6212 of 19/09/2013
27/11/2013 Centralised - 2-Monthly update EMEA/H/C/700/II/45 (2013)8508 of 25/11/2013
25/04/2014 PSUSA - Modification EMEA/H/C/700/PSU/34 (2014)2829 of 23/04/2014
25/09/2014 Centralised - Variation EMEA/H/C/700/II/51
Updated with Decision(2015)6381 of 14/09/2015
26/09/2014 Centralised - Annual reassessment EMEA/H/C/700/S/50
26/03/2015 Centralised - Variation EMEA/H/C/700/II/54
Updated with Decision(2015)6381 of 14/09/2015
23/07/2015 Centralised - Annual reassessment EMEA/H/C/700/S/55
16/09/2015 Centralised - Yearly update (2015)6381 of 14/09/2015
16/10/2015 Centralised - Variation EMEA/H/C/700/IAin/61
22/10/2015 Centralised - Variation EMEA/H/C/700/II/58
31/03/2016 Centralised - Variation EMEA/H/C/700/IB/63