Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Procysbi   
Auth. number : EU/1/13/861
Active substance : mercaptamine (cysteamine bitartrate)
Orphan market exclusivity for "Treatment of cystinosis" (based on designation EU/3/10/778) started on 10/09/2013
   10 years of market exclusivity
   This orphan market exclusivity will expire on 10/09/2023
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: A16AA04 - Mercaptamine
(See WHO ATC Index)
Indication: PROCYSBI is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.
Marketing Authorisation Holder: Chiesi Orphan B.V.
Graadt van Roggenweg 340, 3531 AH Utrecht, Nederland
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
10/09/2013 Centralised - Authorisation EMEA/H/C/2465 (2013)5838 of 06/09/2013
30/06/2014 Centralised - Notification EMEA/H/C/2465/N/4
Updated with Decision(2015)7387 of 22/10/2015
14/10/2014 Centralised - Variation EMEA/H/C/2465/IAin/5
Updated with Decision(2015)7387 of 22/10/2015
26/10/2015 Centralised - Yearly update (2015)7387 of 22/10/2015
16/11/2015 Centralised - Variation EMEA/H/C/2465/IB/9
Updated with Decision(2016)7600 of 18/11/2016
15/12/2015 Centralised - Variation EMEA/H/C/2465/IAin/10
Updated with Decision(2016)7600 of 18/11/2016
05/01/2016 Centralised - Variation EMEA/H/C/2465/IB/11
Updated with Decision(2016)7600 of 18/11/2016
22/12/2016 Centralised - Yearly update (2016)7600 of 18/11/2016
11/01/2017 Centralised - Variation EMEA/H/C/2465/IAin/13
05/09/2017 Centralised - Variation EMEA/H/C/2465/IAin/16
23/11/2017 Centralised - Variation EMEA/H/C/2465/IAin/17