Orphan designation: Equine polyclonal immunoglobulin F(ab')2 fragments against ricin Treatment of ricin poisoning, 22/05/2025 Positive

Orphan designation: Tertomotide Treatment of progressive supranuclear palsy, 22/05/2025 Positive

Orphan designation: recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1 Treatment of calciphylaxis, 22/05/2025 Positive

EMEA-001222-PIP01-11-M01

Opinion/decision on a Paediatric investigation plan (PIP): Constella, linaclotide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastrointestinal disorders, PIP number: P/0529/2022

Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0206/2024

EMEA-003196-PIP01-22-M01

Opinion/decision on a Paediatric investigation plan (PIP): Vanflyta, Quizartinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0203/2024

EMEA-003480-PIP01-23

EMEA-003586-PIP01-24