Rolufta Ellipta (previously Rolufta)
umeclidinium
Pulmonary Disease, Chronic Obstructive
Date of authorisation:
Revision: 12
Last updated:
MedicineHumanAuthorised
Trelegy Ellipta
fluticasone furoate
umeclidinium
vilanterol
Pulmonary Disease, Chronic Obstructive
Date of authorisation:
Revision: 11
Last updated:
MedicineHumanAuthorised
Elebrato Ellipta
fluticasone furoate
umeclidinium
vilanterol
Pulmonary Disease, Chronic Obstructive
Date of authorisation:
Revision: 12
Last updated:
MedicineHumanAuthorised
EMEA-000662-PIP02-09-M05 - paediatric investigation plan
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0548/2022
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Suspension for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000837-PIP01-10-M02 - paediatric investigation plan
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0527/2022
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Suspension for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000838-PIP01-10-M02 - paediatric investigation plan
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0526/2022
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Suspension for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001012-PIP01-10-M01 - paediatric investigation plan
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0086/2019
Route(s) of administration: Sublingual use
Pharmaceutical form(s):
Coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Temybric Ellipta
fluticasone furoate
umeclidinium
vilanterol
Pulmonary Disease, Chronic Obstructive
Date of authorisation:
Revision: 4
Last updated:
MedicineHumanLapsed
EMEA-002153-PIP01-17-M01 - paediatric investigation plan
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0058/2020
Route(s) of administration: Inhalation use
Pharmaceutical form(s):
Inhalation powder (pre-dispensed)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001013-PIP01-10-M01 - paediatric investigation plan
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0085/2019
Route(s) of administration: Sublingual use
Pharmaceutical form(s):
Oromucosal drops
Decision date:
Last updated:
Compliance check: ✖
PIPHuman