Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cystadrops   
Auth. number : EU/1/15/1049
Active substance : mercaptamine
Orphan market exclusivity for "Treatment of cystinosis" (based on designation EU/3/08/578) started on 23/01/2017
   10 years of market exclusivity
   This orphan market exclusivity will expire on 23/01/2027
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01X - Other ophthalmologicals
Chemical subgroup: S01XA - Other ophthalmologicals
Chemical substance: S01XA21 - mercaptamine
(See WHO ATC Index)
Indication: Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.
Marketing Authorisation Holder: Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France
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
23/01/2017 Centralised - Authorisation EMEA/H/C/3769 (2017)378 of 19/01/2017
16/02/2017 Centralised - Variation EMEA/H/C/3769/IA/1/G
Updated with Decision(2018)196 of 11/01/2018
15/01/2018 Centralised - Yearly update (2018)196 of 11/01/2018
30/05/2018 Centralised - Notification EMEA/H/C/3769/N/7
7/11/2018 Centralised - Notification EMEA/H/C/3769/N/9
22/02/2019 Centralised - Notification EMEA/H/C/003769/N/0013