Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ammonaps   
Auth. number : EU/1/99/120
INN : Sodium phenylbutyrate
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: A16AX - Various alimentary tract and metabolism products
Chemical substance: A16AX03 - Sodium phenylbutyrate
(See WHO ATC Index)
Indication: AMMONAPS is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.
Marketing Authorisation Holder: Swedish Orphan International AB
SE-112 76, Stockholm, 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
14/12/1999 Centralised - Authorisation EMEA/H/C/219 (1999)4276 of 08/12/1999
17/01/2001 Centralised - Variation EMEA/H/C/219/I/1 (2001)14 of 15/01/2001
08/06/2001 Centralised - Annual reassessment EMEA/H/C/219/R/3 (2001)1272 of 06/06/2001
02/05/2002 Centralised - Annual reassessment EMEA/H/C/219/S/4 (2002)1824 of 29/04/2002
24/07/2003 Centralised - Annual reassessment EMEA/H/C/219/S/5 (2003)2738 of 22/07/2003
22/12/2003 Centralised - Variation EMEA/H/C/219/IA/10
Updated with Decision(2004)2718 of 06/07/2004
29/01/2004 Centralised - Variation EMEA/H/C/219/II/6 (2004)230 of 27/01/2004
08/07/2004 Centralised - Annual reassessment EMEA/H/C/219/S/8 (2004)2718 of 06/07/2004
02/11/2004 Centralised - Variation EMEA/H/C/219/II/11 (2004)4309 of 28/10/2004
31/03/2005 Centralised - Renewal EMEA/H/C/219/R/12 (2005)1052 of 29/03/2005
16/11/2005 Centralised - Variation EMEA/H/C/219/IA/14
Updated with Decision(2006)1752 of 24/04/2006
16/11/2005 Centralised - Variation EMEA/H/C/219/IA/13
02/02/2006 Centralised - Variation EMEA/H/C/219/IB/15
26/04/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/219/T/16 (2006)1752 of 24/04/2006
30/06/2006 Centralised - Variation EMEA/H/C/219/IA/17
Updated with Decision(2007)602 of 20/02/2007
15/12/2006 Centralised - Variation EMEA/H/C/219/IB/18
21/02/2007 Centralised - Variation EMEA/H/C/219/IA/19
22/02/2007 Centralised - Variation (2007)602 of 20/02/2007
02/03/2007 Centralised - Variation EMEA/H/C/219/IA/21
02/03/2007 Centralised - Variation EMEA/H/C/219/IA/20
05/07/2007 Centralised - Variation EMEA/H/C/219/II/22 (2007)3330 of 03/07/2007
07/11/2007 Centralised - Variation EMEA/H/C/219/II/23 (2007)5426 of 31/10/2007
14/01/2008 Centralised - Variation EMEA/H/C/219/IB/25
17/01/2008 Centralised - Variation EMEA/H/C/219/IA/27
31/01/2008 Centralised - Variation EMEA/H/C/219/IB/24
28/04/2008 Centralised - Variation EMEA/H/C/219/IA/30
05/05/2008 Centralised - Variation EMEA/H/C/219/IA/29
Updated with Decision(2008)8162 of 04/12/2008
29/07/2008 Centralised - Variation EMEA/H/C/219/II/28
02/10/2008 Centralised - Variation EMEA/H/C/219/IA/32
17/11/2008 Centralised - Variation EMEA/H/C/219/IA/33
10/12/2008 Centralised - Variation (2008)8162 of 04/12/2008
27/01/2009 Centralised - Variation EMEA/H/C/219/II/31
19/10/2009 Centralised - Renewal EMEA/H/C/219/R/34 (2009)8005 of 14/10/2009
17/11/2009 Centralised - Variation EMEA/H/C/219/IB/36
10/12/2009 Centralised - Variation EMEA/H/C/219/IB/35
06/01/2010 Centralised - Variation EMEA/H/C/219/IB/37
17/09/2010 Centralised - Variation EMEA/H/C/219/N/38
Updated with Decision(2011)5061 of 07/07/2011
14/12/2010 Centralised - Variation EMEA/H/C/219/IA/39
Updated with Decision(2011)5061 of 07/07/2011
16/12/2010 Centralised - Variation EMEA/H/C/219/IB/40
12/07/2011 Centralised - Variation (2011)5061 of 07/07/2011
15/09/2011 Centralised - Variation EMEA/H/C/219/II/42/G (2011)6521 of 13/09/2011
03/03/2014 Centralised - Variation EMEA/H/C/219/IB/44