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-003294-PIP01-22 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: P/0534/2022
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Solution for injection
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
Xeljanz - referral
tofacitinib
Article 20 procedures
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
Xeljanz
tofacitinib
Arthritis, Rheumatoid
Last updated:
MedicineHumanRefused