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- Pyridoxine and L-pyroglutamic acid
Pharmaceuticals - Community Register
Community register of orphan medicinal products | GRANTED |
Product information |
Pyridoxine and L-pyroglutamic acid
| EU orphan designation number: | EU/3/16/1673
|
| Active ingredient: | Pyridoxine and L-pyroglutamic acid |
| Indication: | Treatment of fragile X syndrome |
| Sponsor: | FGK Representative Service Ltd.
c/o EMW, Seebeck House 1 Seebeck Place, Knowlhill, Milton Keynes, Buckinghamshire MK5 8FR, United Kingdom |
Public summary of scientific opinion
European Commission procedures |
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 29/06/2016 | Orphan designation | EMA/OD/034/16 | (2016)4114 of 27/06/2016 |
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