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Opinion/decision on a Paediatric investigation plan (PIP): Betmiga, Mirabegron, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Renal and urinary disorders, PIP number: P/0085/2024
14 May 2025
Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine, Date of authorisation: 06/01/2021, Revision: 55, Status: Authorised
14 May 2025
Human medicines European public assessment report (EPAR): Isentress, raltegravir, Date of authorisation: 19/12/2007, Revision: 44, Status: Authorised
14 May 2025
Human medicines European public assessment report (EPAR): Kymriah, tisagenlecleucel, Date of authorisation: 23/08/2018, Revision: 19, Status: Authorised
14 May 2025
Human medicines European public assessment report (EPAR): Lyfnua, gefapixant, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised
14 May 2025
Human medicines European public assessment report (EPAR): Paxlovid, nirmatrelvir,ritonavir, Date of authorisation: 28/01/2022, Revision: 26, Status: Authorised
14 May 2025
Human medicines European public assessment report (EPAR): Zabdeno, ebola vaccine (Ad26.ZEBOV-GP [recombinant]), Date of authorisation: 01/07/2020, Revision: 9, Status: Authorised
14 May 2025
Human medicines European public assessment report (EPAR): Mvabea, Ebola vaccine (MVA-BN-Filo [recombinant]), Date of authorisation: 01/07/2020, Revision: 6, Status: Authorised
14 May 2025