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Search results (28185)

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
EMA/PE/0000233803 - paediatric investigation plan
Active substance: chikungunya virus virus-like particle (CHIKV VLP)
Therapeutic area: Infections and infestations
Pharmaceutical form(s): Suspension for injection
Route(s) of administration: Intramuscular use
Decision number: P/0059/2024
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/0000229144 - paediatric investigation plan
Active substance: Respiratory Syncytial Virus stabilised prefusion f subunit vaccine (RSVpreF)
Therapeutic area: Infections and infestations
Pharmaceutical form(s): Powder and solvent for solution for injection
Route(s) of administration: Intramuscular use
Decision number: P/0058/2023
Decision date: 21 March 2025
Decision type: PM: decision on the application for modification of an agreed PIP
Compliance check done: No
Last updated: 18 June 2026
PIPHuman
EMA/PE/0000232890 - paediatric investigation plan
Active substance: clevidipine
Therapeutic area: Vascular disorders
Pharmaceutical form(s): Emulsion for injection
Route(s) of administration: Intravenous use
Decision number: P/0009/2014
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/0000228305 - paediatric investigation plan
Therapeutic area: Skin and subcutaneous tissue disorders
Pharmaceutical form(s): Film-coated tablet, age-appropriate solid dosage form
Route(s) of administration: Oral use
Decision number: P/0008/2024
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
One Health approach

The European Medicines Agency (EMA) and four other health and environment agencies of the European Union (EU) work together to implement the One Health approach. It aims to enable the EU and its Member States to better prevent, predict, detect and respond to health threats.

Last updated: 17 June 2026
HumanVeterinaryMedicines
EMEA-003553-PIP01-23 - paediatric investigation plan
Active substance: oveporexton
Therapeutic area: Nervous system disorders
Pharmaceutical form(s): Film-coated tablet
Route(s) of administration: Oral use
Decision number: EMEA-003553-PIP01-23
Decision date: 19 March 2025
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: 17 June 2026
PIPHuman
EMEA-002568-PIP02-23 - paediatric investigation plan
Active substance: sonelokimab
Therapeutic area: Skin and subcutaneous tissue disorders
Pharmaceutical form(s): Solution for injection
Route(s) of administration: Subcutaneous use
Decision number: EMEA-002568-PIP02-23
Decision date: 21 March 2025
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: 17 June 2026
PIPHuman