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Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Categories
Human Remove Human filter
Medicine type
Conditional approval Remove Conditional approval filter
Generic Remove Generic filter
Additional monitoring Remove Additional monitoring filter
PIP decision type
W: decision granting a waiver in all age groups for all conditions/indications Remove W: decision granting a waiver in all age groups for all conditions/indications filter
RPM: decision refers to a refusal on the application for modification of an agreed PIP Remove RPM: decision refers to a refusal on the application for modification of an agreed PIP filter
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Opinion/decision on a Paediatric investigation plan (PIP): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002153-PIP01-17-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, pre-dispensed
Decision date: 14/02/2020, Last updated: 10/12/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Reagila, Cariprazine (hydrochloride)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001652-PIP01-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 17/03/2021, Last updated: 26/11/2021, Compliance check: X