Page contents Key factsDecisionKey facts Active Substance alvelestat Therapeutic area Congenital, familial and genetic disorders Decision number P/0258/2024 PIP number EMEA-003605-PIP01-24 Pharmaceutical form(s) Film-coated tablet Condition(s) / indication(s) Treatment of congenital alpha-1 antitrypsin deficiency Route(s) of administration Oral use Contact for public enquiries Mereo Biopharma Ireland LimitedE-mail: paediatrics@mereobiopharma.com Tel.: +1 6509958341 Decision type W: decision granting a waiver in all age groups for all conditions or indications Decision date 19/07/2024DecisionP/0258/2024: EMA decision of 19 July 2024 on the granting of a product specific waiver for alvelestat (tosylate) (EMEA-003605-PIP01-24)AdoptedReference Number: EMA/320746/2024 English (EN) (177.31 KB - PDF)First published: 20/06/2025ViewShare this page