Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Holoclar   
Auth. number : EU/1/14/987
Active substance : Ex vivo expanded autologous human corneal epithelial cells containing stem cells
Orphan market exclusivity for "Treatment of corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns" (based on designation EU/3/08/579) started on 19/02/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 19/02/2025
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01X - Other ophthalmologicals
Chemical subgroup: S01XA - Other ophthalmologicals
Chemical substance: S01XA19 - limbal stems cells, autologous
(See WHO ATC Index)
Indication: Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns. A minimum of 1-2 mm2 of undamaged limbus is required for biopsy.
Marketing Authorisation Holder: Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, 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
19/02/2015 Centralised - Authorisation EMEA/H/C/2450 (2015)1028 of 17/02/2015
14/12/2015 Centralised - Annual renewal EMEA/H/C/2450/R/1 (2015)9261 of 10/12/2015
3/11/2016 Centralised - Notification EMEA/H/C/2450/N/10
Updated with Decision(2017)8707 of 11/12/2017
12/12/2016 Centralised - Annual renewal EMEA/H/C/2450/R/8 (2016)8529 of 8/12/2016
22/06/2017 Centralised - Variation EMEA/H/C/2450/II/12/G
Updated with Decision(2017)8707 of 11/12/2017
13/12/2017 Centralised - Annual renewal EMEA/H/C/2450/R/15 (2017)8707 of 11/12/2017
17/01/2019 Centralised - Annual renewal EMEA/H/C/2450/R/21 (2019)272 of 15/01/2019
22/02/2019 Centralised - Notification EMEA/H/C/002450/N/0024