Zeposia
ozanimod
Multiple Sclerosis, Relapsing-Remitting
Colitis, Ulcerative
Date of authorisation:
Revision: 6
Last updated:
MedicineHumanAuthorised
EMEA-001710-PIP02-14-M07 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: P/0392/2022
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Age-appropriate oral solid dosage form
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001710-PIP04-17-M03 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: P/0131/2022
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Age-appropriate oral liquid dosage form
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001710-PIP03-17-M03 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: P/0233/2021
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Age-appropriate oral solid dosage form
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001266-PIP04-19 - 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/0001/2020
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Alsitek
masitinib
Amyotrophic Lateral Sclerosis
Date of refusal:
Last updated:
MedicineHumanRefused
Masipro
masitinib
Mastocytosis
Date of refusal:
Last updated:
MedicineHumanRefused
EMEA-001266-PIP02-14 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: P/0093/2015
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Masivet
masitinib mesilate
Dogs
Date of authorisation:
Revision: 6
Last updated:
MedicineVeterinaryAuthorised