Opinion/decision on a Paediatric investigation plan (PIP): Evkeeza,Evinacumab, decision type: , therapeutic area: , PIP number: P/0394/2022

Human medicines European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau), chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous;Metabolism, Inborn Errors, Date of authorisation: 10/04/2017, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Jinarc, tolvaptan, Polycystic Kidney, Autosomal Dominant, Date of authorisation: 27/05/2015, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR): Viagra, sildenafil, Erectile Dysfunction, Date of authorisation: 13/09/1998, Revision: 45, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Tremelimumab, decision type: , therapeutic area: , PIP number: P/0367/2022

Opinion/decision on a Paediatric investigation plan (PIP): Imfinzi,durvalumab, decision type: , therapeutic area: , PIP number: P/0366/2022

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine hydrochloride, decision type: , therapeutic area: , PIP number: P/0390/2022

Opinion/decision on a Paediatric investigation plan (PIP): Piqray,Alpelisib, decision type: , therapeutic area: , PIP number: P/0412/2022

Orphan designation: 3-{[2,3,5,6-tetrafluoro-3'-(trifluoromethoxy)biphenyl-4-yl]carbamoyl}thiophene-2-carboxylic acid, Treatment of non-infectious uveitis, 19/06/2015, Positive

Opinion/decision on a Paediatric investigation plan (PIP): Anti-CD7 mAb conjugated to ricin toxin A chain,Anti-CD3 mAb conjugated to ricin toxin A chain, decision type: , therapeutic area: , PIP number: P/0369/2022