Human medicines European public assessment report (EPAR): Spevigo, spesolimab, Date of authorisation: 09/12/2022, Revision: 5, Status: Authorised

Submitted by Anonymous (not verified) on 14 April 2026 - 11:52

Human medicines European public assessment report (EPAR): Spevigo, spesolimab, Date of authorisation: 09/12/2022, Revision: 5, Status: Authorised

Orphan designation: adeno-associated viral vector serotype 44.9 containing the human HRS1 gene Treatment of inherited retinal dystrophy due to dysfunction in the human retinoschisin (RS1) gene, 23/02/2026 Positive

Submitted by Anonymous (not verified) on 14 April 2026 - 9:53

Orphan designation: adeno-associated viral vector serotype 44.9 containing the human HRS1 gene Treatment of inherited retinal dystrophy due to dysfunction in the human retinoschisin (RS1) gene, 23/02/2026 Positive

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