Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Kuvan   
Auth. number : EU/1/08/481
INN : sapropterin dihydrochloride
Orphan status based on designation EU/3/04/199 added on 04/12/2008
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: A16AX07 - Sapropterin
(See WHO ATC Index)
Indication: Kuvan is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of 4 years of age and over with phenylketonuria (PKU), who have been shown to be responsive to such treatment).
Kuvan is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.
Marketing Authorisation Holder: Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom

  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
04/12/2008 Centralised - Authorisation EMEA/H/C/943 (2008)8006 of 02/12/2008
22/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/943/IA/1
22/12/2008 Centralised - Variation EMEA/H/C/943/IA/2
Updated with Decision(2009)6071 of 24/07/2009
07/07/2009 Centralised - Notification EMEA/H/C/943/N/4
Updated with Decision(2011)5529 of 26/07/2011
30/07/2009 Centralised - Variation (2009)6071 of 24/07/2009
07/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/943/IB/5
12/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/943/II/3
25/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/943/II/6
09/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/943/IA/9
09/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/943/IB/8/G
18/05/2010 Centralised - Variation EMEA/H/C/943/II/7 (2010)3216 of 12/05/2010
18/06/2010 Centralised - Variation EMEA/H/C/943/IB/10
Updated with Decision(2011)294 of 17/01/2011
19/01/2011 Centralised - Variation (2011)294 of 17/01/2011
25/01/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/943/T/11 (2011)385 of 21/01/2011
28/07/2011 Centralised - Variation EMEA/H/C/943/II/12 (2011)5529 of 26/07/2011
30/05/2012 Centralised - Variation EMEA/H/C/943/II/15 (2012)3568 of 25/05/2012
15/11/2013 Centralised - Renewal EMEA/H/C/943/R/26 (2013)8067 of 13/11/2013