EMEA-001397-PIP04-17-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0421/2019
Route(s) of administration: Oral useGastric use
Pharmaceutical form(s):
Capsule (hard)
Film-coated tablet
Oral suspension
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Imbruvica
ibrutinib
Lymphoma, Mantle-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation:
Revision: 33
Last updated:
MedicineHumanAuthorised
EMEA-001397-PIP03-14-M06 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: P/0337/2021
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
EMEA-001397-PIP06-17 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/0297/2017
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001397-PIP05-17 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/0298/2017
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001397-PIP02-13 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/0271/2014
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001397-PIP01-12 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: P/0149/2013
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman