Apremilast Accord
apremilast
Arthritis, Psoriatic
Psoriasis
Behcet Syndrome
Oral Ulcer
Date of authorisation:
Last updated:
MedicineHumanAuthorised
Otezla
apremilast
Arthritis, Psoriatic
Psoriasis
Date of authorisation:
Revision: 22
Last updated:
MedicineHumanAuthorised
EMEA-000715-PIP02-11-M06 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0352/2022
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Oral liquid
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000715-PIP05-13-M05 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0353/2022
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Oral suspension
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000715-PIP03-11-M06 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0469/2020
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Oral liquid
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Qsiva
phentermine
topiramate
Obesity
Date of refusal:
Last updated:
MedicineHumanRefused
EMEA-000826-PIP01-09 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: P/223/2010
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman