EMEA-000576-PIP01-09-M14 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0102/2023
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Prolonged-release film-coated tablet
Oral solution
Prolonged-release age-appropriate oral formulation
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Xeljanz
tofacitinib
Arthritis, Rheumatoid
Date of authorisation:
Date of refusal:
Revision: 29
Last updated:
MedicineHumanAuthorised
EMEA-000576-PIP02-11-M04 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: P/0055/2017
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Oral solution
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Janus kinase inhibitors (JAKi) - referral
tofacitinib
abrocitinib
baricitinib
upadacitinib
filgotinib
Article 20 procedures
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
EMEA-000576-PIP03-12-M06 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: P/0439/2022
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Oral solution
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001545-PIP01-13-M02 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: P/0065/2020
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Powder and solvent for suspension for injection
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
EMEA-001888-PIP01-15-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: P/0429/2020
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Powder and solvent for solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman