Opinion/decision on a Paediatric investigation plan (PIP): Biktarvy, bictegravir,emtricitabine,tenofovir alafenamide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number:…
P/0242/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy), (EMEA-001766-PIP01-15-M05)
Reference Number: EMA/250921/2023