Human medicines European public assessment report (EPAR): Tadalafil Lilly, tadalafil, Erectile Dysfunction, Date of authorisation: 22/03/2017, Revision: 6, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Corticotropin, decision type: , therapeutic area: , PIP number: P/0384/2022

Opinion/decision on a Paediatric investigation plan (PIP): Etranacogene dezaparvovec, decision type: , therapeutic area: , PIP number: P/0380/2022

Human medicines European public assessment report (EPAR): Lynparza, olaparib, Ovarian Neoplasms, Date of authorisation: 16/12/2014, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Infanrix Hexa, diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed), Hepatitis B;Tetanus;Immunization;Meningitis, Haemophilus;Whooping Cough;Poliomyelitis;Diphtheria, Date of authorisation: 23/10/2000, Revision: 47, Status: Authorised

Orphan designation: Talquetamab, Treatment of multiple myeloma, 20/08/2021, Positive

List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)

Periodic safety update reports (PSURs)

Human medicines European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 Vaccine (ChAdOx1-S [recombinant]), COVID-19 virus infection, Date of authorisation: 29/01/2021, Revision: 30, Status: Authorised

Industry annual bilateral meetings