Search

Filter by

Categories
Document type
Type of content
Topics
Responsible body
Last updated
First published

Search results (25692)

Xeljanz
tofacitinib
Arthritis, Rheumatoid
Date of refusal:
Revision: 34
Last updated: 24 March 2025
MedicineHumanAuthorised
EMEA-002342-PIP01-18-M04 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: P/0037/2024
Route(s) of administration: Oral use
Pharmaceutical form(s): Film-coated tablet
Decision date: 7 February 2024
Last updated: 24 March 2025
Compliance check: ✖
PIPHuman
EMEA-000877-PIP03-17-M05 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: P/0021/2024
Route(s) of administration: Perineural use; Infiltration use
Pharmaceutical form(s): Prolonged-release dispersion for injection, Dispersion for injection
Decision date: 9 February 2024
Last updated: 24 March 2025
Compliance check: ✖
PIPHuman
Paediatric investigation plans: questions and answers

This page provides answers to specific questions from companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver. Information is also available for companies that already have an agreed PIP.

Last updated: 24 March 2025
HumanRegulatory and procedural guidancePaediatricsResearch and development
Seladelpar Gilead
Seladelpar lysine dihydrate
Liver Cirrhosis, Biliary
Revision: 1
Last updated: 24 March 2025
MedicineHumanAuthorised
Siiltibcy
Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10)
Tuberculosis, Diagnosis
Date of authorisation:
Revision: 1
Last updated: 24 March 2025
MedicineHumanAuthorised
EMEA-000574-PIP03-23 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Blood and lymphatic system disorders
PIP number: P/0040/2024
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s): Powder for solution for injection
Decision date: 7 February 2024
Last updated: 24 March 2025
Compliance check: ✖
PIPHuman
Back to top