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EMA/PE/0000231366 - paediatric investigation plan
Active substance: efgartigimod alfa
Therapeutic area: Nervous system disorders
Pharmaceutical form(s): Concentrate for solution for infusion
Route(s) of administration: Intravenous use
Decision number: P/0298/2024
Decision date: 21 March 2025
Decision type: PM: decision on the application for modification of an agreed PIP
Compliance check done: No
Last updated: 19 June 2026
PIPHuman
EMA/PE/0000228536 - paediatric investigation plan
Active substance: enlicitide (decanoate)
Therapeutic area: Metabolism and nutrition disorders
Pharmaceutical form(s): Film-coated tablet, Age-appropriate formulation
Route(s) of administration: Oral use
Decision number: P/0133/2024
Decision date: 19 March 2025
Decision type: PM: decision on the application for modification of an agreed PIP
Compliance check done: No
Last updated: 19 June 2026
PIPHuman
EMA/PE/0000228081 - paediatric investigation plan
Active substance: voclosporin
Therapeutic area: Musculoskeletal and connective tissue disorders
Pharmaceutical form(s): Capsule, soft
Route(s) of administration: Oral use
Decision number: P/0152/2019
Decision date: 19 March 2025
Decision type: PM: decision on the application for modification of an agreed PIP
Compliance check done: No
Last updated: 19 June 2026
PIPHuman
EMA/PE/0000189672 - paediatric investigation plan
Active substance: obefazimod
Therapeutic area: Gastrointestinal disorders
Pharmaceutical form(s): Capsule, hard, Oral solution
Route(s) of administration: Oral use
Decision number: P/0205/2024
Decision date: 20 March 2025
Decision type: PM: decision on the application for modification of an agreed PIP
Compliance check done: No
Last updated: 19 June 2026
PIPHuman
EMA/PE/0000233797 - paediatric investigation plan
Active substance: delandistrogene moxeparvovec
Therapeutic area: Congenital, familial and genetic disorders
Pharmaceutical form(s): Solution for infusion
Route(s) of administration: Intravenous use
Decision number: P/0325/2023
Decision date: 21 March 2025
Decision type: PM: decision on the application for modification of an agreed PIP
Compliance check done: No
Last updated: 19 June 2026
PIPHuman
Leqembi
INN or common name:lecanemab
Therapeutic area (MeSH):Cognitive Dysfunction; Alzheimer Disease
Marketing authorisation issued:
Last updated:19 June 2026
Revision: 4
Additional monitoring
MedicineHumanAuthorised
Semglee
INN or common name:insulin glargine
Therapeutic area (MeSH):Diabetes Mellitus
Marketing authorisation issued:
Last updated:19 June 2026
Revision: 11
Biosimilar
MedicineHumanAuthorised
EMA/PE/0000227963 - paediatric investigation plan
Active substance: catequentinib (dihydrochloride)
Therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharmaceutical form(s): Capsule, hard, Age-appropriate oral dosage formulation
Route(s) of administration: Oral use
Decision number: P/0110/2024
Decision date: 21 March 2025
Decision type: PM: decision on the application for modification of an agreed PIP
Compliance check done: No
Last updated: 18 June 2026
PIPHuman
EMA/PE/0000232680 - paediatric investigation plan
Active substance: ustekinumab
Therapeutic area: Gastrointestinal disorders
Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Route(s) of administration: Intravenous use; Subcutaneous use
Decision number: P/0084/2021
Decision date: 21 March 2025
Decision type: PM: decision on the application for modification of an agreed PIP
Compliance check done: No
Last updated: 18 June 2026
PIPHuman