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- Ursodeoxycholic acid
Pharmaceuticals - Community Register
Community register of orphan medicinal products | GRANTED |
Product information |
Ursodeoxycholic acid
| EU orphan designation number: | EU/3/17/1878
|
| Active ingredient: | Ursodeoxycholic acid |
| Indication: | Treatment of Niemann-Pick disease |
| Sponsor: | IntraBio Ltd
University of Oxford Begbroke Science Park, Begbroke Hill,Woodstock Road,Begbroke, Oxfordshire OX5 1PF, United Kingdom |
Public summary of scientific opinion
European Commission procedures |
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 23/05/2017 | Orphan designation | EMA/OD/316/16 | (2017)3611 of 22/05/2017 |
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