Summary of opinion: Albrioza,sodium phenylbutyrate,Ursodoxicoltaurine, 22/06/2023, Negative
The European Medicines Agency has recommended the refusal of the marketing authorisation for Albrioza, a medicine intended for the treatment of amyotrophic lateral sclerosis (ALS).
The Agency issued its opinion on 22 June 2023. The company that applied for authorisation, Amylyx Pharmaceuticals EMEA B.V., may ask for re-examination of the opinion within 15 days of receiving the opinion.
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