Orphan designation: (S)-1-(5-((2,3-dihydro-[1,4]dioxino[2,3-b]pyridin-7-yl)sulfonyl)-3,4,5,6-tetrahydropyrrolo[3,4-c]pyrrol-2(1H)-yl)-3-hydroxy-2-phenylpropan-1-one, Treatment of sickle cell disease, 19/10/2020, Positive

Human medicines European public assessment report (EPAR): Procysbi, mercaptamine, Cystinosis, Date of authorisation: 05/09/2013, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Retsevmo, selpercatinib, Carcinoma, Non-Small-Cell Lung;Thyroid Neoplasms, Date of authorisation: 11/02/2021, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Fortacin, lidocaine,prilocaine, Sexual Dysfunction, Physiological, Date of authorisation: 15/11/2013, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Vitrakvi, larotrectinib, Abdominal Neoplasms, Date of authorisation: 19/09/2019, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Tenkasi (previously Orbactiv), oritavancin, Soft Tissue Infections;Skin Diseases, Bacterial, Date of authorisation: 19/03/2015, Revision: 14, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy- 10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,- 14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]- oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyldimethyl-phosphinate (MK-8669, or AP23573), decision type: , therapeutic area: , PIP number: P/2/2010

Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 11-14 September 2023

Agenda of the HMPC meeting 18-20 September 2023

Opinion/decision on a Paediatric investigation plan (PIP): Etrasimod L-arginine, decision type: , therapeutic area: , PIP number: P/0409/2022