Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Carbaglu   
Auth. number : EU/1/02/246
Active substance : Carglumic acid
Orphan market exclusivity for "Treatment of N-acetylglutamate synthetase (NAGS) deficiency" (based on designation EU/3/00/007) started on 28/01/2003
   10 years of market exclusivity
   This orphan market exclusivity has ended on 28/01/2013
Orphan market exclusivity for "Treatment of isovaleric acidaemia" (based on designation EU/3/08/575) started on 01/06/2011
   10 years of market exclusivity
   This orphan market exclusivity will expire on 01/06/2021
Orphan market exclusivity for "Treatment of methylmalonic acidaemia" (based on designation EU/3/08/576) started on 01/06/2011
   10 years of market exclusivity
   This orphan market exclusivity will expire on 01/06/2021
Orphan market exclusivity for "Treatment of propionic acidaemia" (based on designation EU/3/08/577) started on 01/06/2011
   10 years of market exclusivity
   This orphan market exclusivity will expire on 01/06/2021
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: A16AA - Amino acids and derivatives
Chemical substance: A16AA05 - Carglumic acid
(See WHO ATC Index)
Indication: Carbaglu is indicated in treatment of
  • hyperammonaemia due to N-acetylglutamate synthase primary deficiency.
  • hyperammonaemia due to isovaleric acidaemia.
  • hyperammonaemia due to methymalonic acidaemia.
  • hyperammonaemia due to propionic acidaemia.
Marketing Authorisation Holder: Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France
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
28/01/2003 Centralised - Authorisation EMEA/H/C/461 (2003)416 of 24/01/2003
05/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/461/IA/2
23/09/2004 Centralised - Annual reassessment EMEA/H/C/461/S/1 (2004)3594 of 21/09/2004
30/09/2004 Centralised - Variation EMEA/H/C/461/IB/3
Updated with Decision(2005)1395 of 27/04/2005
07/12/2004 Centralised - Variation EMEA/H/C/461/IB/4
Updated with Decision(2005)1395 of 27/04/2005
27/04/2005 Centralised - Annual reassessment EMEA/H/C/461/S/7
29/04/2005 Centralised - Variation EMEA/H/C/461/II/5, 6 (2005)1395 of 27/04/2005
28/06/2006 Centralised - Annual reassessment EMEA/H/C/461/S/8 (2006)3004 of 26/06/2006
18/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/461/IA/9
24/09/2007 Centralised - Variation EMEA/H/C/461/IA/10
Updated with Decision(2008)2022 of 20/05/2008
22/05/2008 Centralised - Renewal EMEA/H/C/461/R/11 (2008)2022 of 20/05/2008
21/09/2009 Centralised - Variation EMEA/H/C/461/IA/12
Updated with Decision(2010)1818 of 15/03/2010
17/03/2010 Centralised - Variation (2010)1818 of 15/03/2010
01/06/2011 Centralised - Variation EMEA/H/C/461/II/13 (2011)3874 of 27/05/2011
16/08/2011 Centralised - Variation EMEA/H/C/461/IA/16
Updated with Decision(2012)1862 of 15/03/2012
19/03/2012 Centralised - Variation (2012)1862 of 15/03/2012
31/08/2012 Centralised - Notification EMEA/H/C/461/N/17
Updated with Decision(2014)3130 of 07/05/2014
28/01/2013 Centralised - (orphan status)
24/04/2013 Centralised - Variation EMEA/H/C/461/IB/18
Updated with Decision(2014)3130 of 07/05/2014
19/12/2013 Centralised - Variation EMEA/H/C/461/IG/392
Updated with Decision(2014)3130 of 07/05/2014
09/05/2014 Centralised - Yearly update (2014)3130 of 07/05/2014
31/03/2015 Centralised - Notification EMEA/H/C/461/N/25
Updated with Decision(2015)8324 of 19/11/2015
19/08/2015 Centralised - Variation EMEA/H/C/461/IB/27/G
Updated with Decision(2015)8324 of 19/11/2015
23/11/2015 PSUSA - Modification EMEA/H/C/461/PSUSA/564/201501 (2015)8324 of 19/11/2015