Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Kuvan   
Auth. number : EU/1/08/481
Active substance : sapropterin dihydrochloride
Orphan market exclusivity for "Treatment of hyperphenylalaninemia" (based on designation EU/3/04/199) started on 04/12/2008
   10 years of market exclusivity
   2 additional years of market exclusivity as paediatric reward granted on 24/06/2015
   This orphan market exclusivity will expire on 04/12/2020
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 all ages 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: BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, Ireland
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 EMEA/H/C/943/IA/2
Updated with Decision(2009)6071 of 24/07/2009
22/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/943/IA/1
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/IB/8/G
09/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/943/IA/9
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
18/12/2014 Centralised - Variation EMEA/H/C/943/II/34
Updated with Decision(2015)4369 of 22/06/2015
24/06/2015 Centralised - 2-Monthly update EMEA/H/C/943/II/33 (2015)4369 of 22/06/2015
11/01/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/943/T/40 (2016)75 of 07/01/2016
27/01/2016 Centralised - Variation EMEA/H/C/943/IA/41
Updated with Decision(2017)167 of 11/01/2017
13/01/2017 Centralised - Yearly update (2017)167 of 11/01/2017
23/03/2017 Centralised - Variation EMEA/H/C/943/II/46
Updated with Decision(2017)5083 of 13/07/2017
22/06/2017 Centralised - Variation EMEA/H/C/943/II/48/G
17/07/2017 Centralised - Variation EMEA/H/C/943/X/47 (2017)5083 of 13/07/2017