Human medicines European public assessment report (EPAR): Strimvelis, autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence, Severe Combined Immunodeficiency, Date of authorisation: 26/05/2016, Revision: 9, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Olumiant,Baricitinib, decision type: , therapeutic area: , PIP number: P/0364/2022

Opinion/decision on a Paediatric investigation plan (PIP): Vocabria,Cabotegravir, decision type: , therapeutic area: , PIP number: P/0396/2022

Opinion/decision on a Paediatric investigation plan (PIP): Besponsa,Inotuzumab ozogamicin, decision type: , therapeutic area: , PIP number: P/0398/2022

Opinion/decision on a Paediatric investigation plan (PIP): Tremfya,Guselkumab, decision type: , therapeutic area: , PIP number: P/0399/2022

Opinion/decision on a Paediatric investigation plan (PIP): Roxadustat, decision type: , therapeutic area: , PIP number: P/0400/2022

Opinion/decision on a Paediatric investigation plan (PIP): Descovy,emtricitabine,tenofovir alafenamide, decision type: , therapeutic area: , PIP number: P/0402/2022

Opinion/decision on a Paediatric investigation plan (PIP): Epcoritamab, decision type: , therapeutic area: , PIP number: P/0415/2022

Orphan designation: Celecoxib,Ciprofloxacin, Treatment of amyotrophic lateral sclerosis, 06/01/2021, Positive

Human medicines European public assessment report (EPAR): Steglujan, ertugliflozin,sitagliptin, Diabetes Mellitus, Type 2, Date of authorisation: 23/03/2018, Revision: 11, Status: Authorised