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- Ex-vivo expanded autologous human corneal epithelium contain
Pharmaceuticals - Community Register
Community register of orphan medicinal products | GRANTED |
Product information |
Ex-vivo expanded autologous human corneal epithelium containing stem cells
| EU orphan designation number: | EU/3/08/579
|
| Active ingredient: | Ex-vivo expanded autologous human corneal epithelium containing stem cells |
| Indication: | Treatment of corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns |
| Sponsor: | Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia |
| EU Centralised marketing authorisation: | A centralised EU marketing authorisation has been obtained under the name Holoclar on 17/02/2015 with the number EU/1/14/987 |
Public summary of scientific opinion
EPAR
European Commission procedures |
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 11/11/2008 | Orphan designation | EMEA/OD/025/08 | (2008)6858 of 07/11/2008 |
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