EMEA-002981-PIP01-21 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: P/0504/2021
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Paediatric investigation plans: submitting documents

This page provides detailed guidance for companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver, as well as for companies that already have an agreed PIP.

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HumanRegulatory and procedural guidancePaediatricsResearch and development
EMEA-000727-PIP01-09-M07 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: P/0336/2023
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001821-PIP01-15-M06 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: P/0091/2023
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Powder for oral solution
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-002063-PIP01-16-M02 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0068/2023
Route(s) of administration: Inhalation use
Pharmaceutical form(s):
Pressurised inhalation
Suspension
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-002070-PIP01-16-M07 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: P/0086/2023
Route(s) of administration: Oral use
Pharmaceutical form(s):
Powder for oral solution
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-002079-PIP01-16-M03 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: P/0070/2023
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman