Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: OXERVATE   
Auth. number : EU/1/17/1197
Active substance : cenegermin
Orphan market exclusivity for "Treatment of neurotrophic keratitis" (based on designation EU/3/15/1586) started on 10/07/2017
   10 years of market exclusivity
   This orphan market exclusivity will expire on 10/07/2027
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01X - Other ophthalmologicals
Chemical subgroup: S01XA - Other ophthalmologicals
Chemical substance: S01XA24 - cenegermin
(See WHO ATC Index)
Indication: Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.
Marketing Authorisation Holder: Dompé farmaceutici S.p.A.
Via Santa Lucia 6, 20122 Milano, Italia
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
10/07/2017 Centralised - Authorisation EMEA/H/C/4209 (2017) 4940 of 6/07/2017
15/05/2018 Corrigendum (2018)4940 of 6/07/2017