Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ravicti   
Auth. number : EU/1/15/1062
Active substance : Glycerol phenylbutyrate
Orphan market exclusivity for "Treatment of carbamoyl-phosphate synthase-1 deficiency" (based on designation EU/3/10/733) started on 1/12/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/12/2025
Orphan market exclusivity for "Treatment of ornithine carbamoyltransferase deficiency" (based on designation EU/3/10/734) started on 1/12/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/12/2025
Orphan market exclusivity for "Treatment of citrullinaemia type 1" (based on designation EU/3/10/735) started on 1/12/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/12/2025
Orphan market exclusivity for "Treatment of argininosuccinic aciduria" (based on designation EU/3/10/736) started on 1/12/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/12/2025
Orphan market exclusivity for "Treatment of hyperargininaemia" (based on designation EU/3/10/737) started on 1/12/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/12/2025
Orphan market exclusivity for "Treatment of ornithine translocase deficiency (hyperornithinaemia-hyperammonaemia homocitrullinuria (HHH) syndrome)" (based on designation EU/3/10/738) started on 1/12/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/12/2025
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: A16AX09 - glycerol phenylbutyrate
(See WHO ATC Index)
Indication: RAVICTI is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate synthetase I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).
Marketing Authorisation Holder: Horizon Pharma Ireland Limited
Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, 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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
1/12/2015 Centralised - Authorisation EMEA/H/C/3822 (2015)8592 of 27/11/2015
3/03/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/3822/T/1 (2016)1279 of 24/02/2016
21/03/2016 Centralised - Variation EMEA/H/C/3822/IB/3
Updated with Decision(2017)1221 of 16/02/2017
12/05/2016 Centralised - Variation EMEA/H/C/3822/II/4
Updated with Decision(2017)1221 of 16/02/2017
11/01/2017 Centralised - Variation EMEA/H/C/3822/IB/7
Updated with Decision(2017)1221 of 16/02/2017
20/02/2017 Centralised - Yearly update (2017)1221 of 16/02/2017
10/03/2017 Centralised - Notification EMEA/H/C/3822/N/9
Updated with Decision(2018)2302 of 12/04/2018
3/05/2017 Centralised - Variation EMEA/H/C/3822/IA/10/G
Updated with Decision(2018)2302 of 12/04/2018
8/05/2017 Centralised - Notification EMEA/H/C/3822/N/11
Updated with Decision(2018)2302 of 12/04/2018
27/02/2018 Centralised - Variation EMEA/H/C/3822/IB/17
Updated with Decision(2018)2302 of 12/04/2018
16/04/2018 Centralised - Yearly update (2018)2302 of 12/04/2018
23/05/2018 Centralised - Variation EMEA/H/C/3822/IB/21
Updated with Decision(2018)9126 of 18/12/2018
18/10/2018 Centralised - Variation EMEA/H/C/3822/II/23
Updated with Decision(2018)9126 of 18/12/2018
20/12/2018 Centralised - 2-Monthly update EMEA/H/C/3822/II/19 (2018)9126 of 18/12/2018