EMEA-001220-PIP01-11-M07 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0063/2023
Route(s) of administration: Oral use
Pharmaceutical form(s):
Oral suspension
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001220-PIP07-20-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: P/0364/2022
Route(s) of administration: Gastric useOral use
Pharmaceutical form(s):
Age-appropriate oral liquid dosage form
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001220-PIP03-16-M02 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: P/0311/2021
Route(s) of administration: Oral use
Pharmaceutical form(s):
Oral suspension
Tablet
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-001220-PIP05-19 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0070/2020
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Age-appropriate oral formulation
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001220-PIP08-20 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0339/2021
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Oral suspension
Decision date:
Last updated:
Compliance check: ✖
PIPHuman