EMEA-000115-PIP01-07-M13 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: P/0196/2023
Route(s) of administration: Oral use
Pharmaceutical form(s):
Granules for oral suspension
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Translarna
ataluren
Muscular Dystrophy, Duchenne
Date of authorisation:
Revision: 23
Last updated:
MedicineHumanAuthorised
Gefitinib Mylan
gefitinib
Carcinoma, Non-Small-Cell Lung
Date of authorisation:
Revision: 6
Last updated:
MedicineHumanAuthorised
Iressa
gefitinib
Carcinoma, Non-Small-Cell Lung
Date of authorisation:
Revision: 16
Last updated:
MedicineHumanAuthorised
EMEA-000115-PIP02-09-M03 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0284/2016
Route(s) of administration: Oral use
Pharmaceutical form(s):
Granules for oral suspension
Decision date:
Last updated:
Compliance check: ✖
PIPHuman