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- (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5
Community Register of medicinal products
Community register of orphan medicinal products | GRANTED |
Product information |
(2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid
| EU orphan designation number: | EU/3/12/1040
|
| Active ingredient: | (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid |
| Indication: | Treatment of Alagille syndrome |
| Sponsor: | Albireo AB
Arvid Wallgrens Backe 20, SE-413 46 Gothenburg, Sverige |
Public summary of scientific opinion
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 13/08/2012 | Centralised Orphan - Designation | EMA/OD/023/12 | (2012)5803 of 09/08/2012 |