Orphan designation: methotrexate Treatment of primary large B-cell lymphoma of immune-privileged sites, 22/08/2025 Positive

Orphan designation: sonpiretigene isteparvovec Treatment of non-syndromic inherited retinal dystrophies of the cone-dominant phenotype, 22/08/2025 Positive

EMEA-003071-PIP02-23

Human medicines European public assessment report (EPAR): Mynzepli, aflibercept, Date of authorisation: 18/08/2025, Revision: 1, Status: Authorised

Orphan designation: leuconostoc citreum, strain G511, Live Treatment of primary sclerosing cholangitis, 21/11/2025 Positive

Human medicines European public assessment report (EPAR): Myclausen, mycophenolate mofetil, Date of authorisation: 07/10/2010, Revision: 17, Status: Authorised

Orphan designation: orvepitant maleate Treatment of idiopathic pulmonary fibrosis, 21/11/2025 Positive

Human medicines European public assessment report (EPAR): Abrysvo, respiratory syncytial virus vaccine (bivalent, recombinant), Date of authorisation: 23/08/2023, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): CellCept, mycophenolate mofetil, Date of authorisation: 14/02/1996, Revision: 42, Status: Authorised

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