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EMEA-003556-PIP02-24 - paediatric investigation plan
Active substance: tulisokibart
Therapeutic area: Gastrointestinal disorders
Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection, Age appropriate dosage form for parenteral use
Route(s) of administration: Intravenous use; Subcutaneous use
Decision number: P/0393/2024
Decision date: 6 December 2024
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance check done: No
Last updated: 8 December 2025
PIPHuman
EMEA-003556-PIP01-23 - paediatric investigation plan
Active substance: tulisokibart
Therapeutic area: Gastrointestinal disorders
Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection, Age appropriate dosage form for parenteral use
Route(s) of administration: Intravenous use; Subcutaneous use
Decision number: P/0390/2024
Decision date: 6 December 2024
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance check done: No
Last updated: 8 December 2025
PIPHuman
EMEA-003506-PIP01-23 - paediatric investigation plan
Active substance: doruxapapogenum ralaplasmidum
Therapeutic area: Infections and infestations
Pharmaceutical form(s): Solution for injection
Route(s) of administration: Intramuscular use
Decision number: P/0391/2024
Decision date: 6 December 2024
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance check done: No
Last updated: 8 December 2025
PIPHuman
EMEA-002978-PIP02-24 - paediatric investigation plan
Active substance: trastuzumab deruxtecan
Therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharmaceutical form(s): Powder for concentrate for solution for infusion
Route(s) of administration: Intravenous use
Decision number: P/0397/2024
Decision date: 5 December 2024
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance check done: No
Last updated: 8 December 2025
PIPHuman
EMA/PE/0000225184 - paediatric investigation plan
Active substance: nirmatrelvir; ritonavir
Therapeutic area: Surgical and medical procedures
Pharmaceutical form(s): Film-coated tablet, Age appropriate oral dosage formulation
Route(s) of administration: Oral use
Decision number: EMA/PE/0000225184
Decision date: 6 December 2024
Decision type: PM: decision on the application for modification of an agreed PIP
Compliance check done: No
Last updated: 8 December 2025
PIPHuman
Althaeae radix - herbal medicinal product
English common name: Marshmallow Root
Botanical name: Althaea officinalis L.
Status: F: Assessment finalised
Last updated: 8 December 2025
Herbal productHumanHerbal
Palforzia
INN or common name: defatted powder of Arachis hypogaea L., semen (peanuts)
Therapeutic area (MeSH): Peanut Hypersensitivity
Marketing authorisation issued:
Last updated: 8 December 2025
Revision: 11
Additional monitoring
MedicineHumanAuthorised
Tecartus
INN or common name: brexucabtagene autoleucel
Therapeutic area (MeSH): Lymphoma, Mantle-Cell
Marketing authorisation issued:
Last updated: 8 December 2025
Revision: 16
Additional monitoring
Advanced therapy
Conditional approval
Orphan
PRIME: priority medicine
MedicineHumanAuthorised