Orphan designation: 4-Amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride (ronopterin), Treatment of moderate and severe traumatic brain injury, 28/08/2006, Positive

Human medicines European public assessment report (EPAR): Mircera, methoxy polyethylene glycol-epoetin beta, Anemia;Kidney Failure, Chronic, Date of authorisation: 20/07/2007, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Osteoporosis, Postmenopausal, Date of authorisation: 23/02/2004, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR): Trodelvy, sacituzumab govitecan, Breast Neoplasms;Triple Negative Breast Neoplasms, Date of authorisation: 22/11/2021, Revision: 3, Status: Authorised

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Human medicines European public assessment report (EPAR): Ilumetri, tildrakizumab, Psoriasis, Date of authorisation: 17/09/2018, Revision: 10, Status: Authorised

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