{"dataset":"eu-medicines","sample":[{"id":"EMEA/H/C/005392","record_type":"medicine","category":"human","name":"Padcev","active_substance":"Enfortumab vedotin","inn":"enfortumab vedotin","atc_code":"L01FX13","therapeutic_areas":["Carcinoma, Transitional Cell","Urologic Neoplasms"],"status":"Authorised","holder":"Astellas Pharma Europe B.V.","published":"2022-05-05","updated":"2026-10-16","summary":"Muscle invasive bladder cancer (MIBC) Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC). Unresectable or metastatic urothelial cancer Padcev, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. Locally advanced or metastatic urothelial cancer Padcev as monotherap…","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/padcev","pharmacotherapeutic_group":"Antineoplastic agents","species":[],"flags":["additional_monitoring"],"authorisation_date":"2022-04-13","ec_decision_date":"2026-10-15","withdrawal_date":null,"verification":"official-publication","paid_placement":false,"source_id":"ema-medicines-json","source_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/padcev","retrieved_at":"2026-10-17T20:21:43.732278+00:00","ongoing_shortage":false,"shortage_url":null,"dhpc_urls":[]},{"id":"SHORTAGE-human-normal-immunoglobulins","record_type":"shortage","category":"human","name":"Human normal immunoglobulins","active_substance":null,"inn":"human normal immunoglobulins","atc_code":null,"therapeutic_areas":["Primary Immunodeficiency Diseases","Immunologic Deficiency Syndromes"],"status":"Shortage ongoing","holder":null,"published":"2024-06-03","updated":"2026-09-22","summary":"Solution for injection/infusion","url":"https://www.ema.europa.eu/en/medicines/human/shortages/human-normal-immunoglobulins","alternatives_available":"Yes","shortage_start":null,"expected_resolution":"March 2027","verification":"official-publication","paid_placement":false,"source_id":"ema-medicines-json","source_url":"https://www.ema.europa.eu/en/medicines/human/shortages/human-normal-immunoglobulins","retrieved_at":"2026-10-17T20:21:43.732278+00:00"},{"id":"DHPC-ocrevus","record_type":"safety-communication","category":"human","name":"Ocrevus","active_substance":"ocrelizumab","inn":null,"atc_code":"L04AG08","therapeutic_areas":["Multiple Sclerosis"],"status":"Variation","holder":null,"published":"2026-10-09","updated":"2026-10-09","summary":"Adverse event; Post-authorisation measure","url":"https://www.ema.europa.eu/en/medicines/dhpc/ocrevus","dhpc_types":["Adverse event","Post-authorisation measure"],"procedure_number":"EMA/VR/0000313041","dissemination_date":"2026-10-08","species":[],"verification":"official-publication","paid_placement":false,"source_id":"ema-medicines-json","source_url":"https://www.ema.europa.eu/en/medicines/dhpc/ocrevus","retrieved_at":"2026-10-17T20:21:43.732278+00:00"},{"id":"REFERRAL-rifadin-oral-suspension-syrup-associated-names","record_type":"referral","category":"human","name":"Rifadin oral suspension and syrup and associated names","active_substance":null,"inn":"rifampicin","atc_code":null,"therapeutic_areas":[],"status":"Procedure started","holder":null,"published":"2026-06-26","updated":"2026-10-15","summary":null,"url":"https://www.ema.europa.eu/en/medicines/human/referrals/rifadin-oral-suspension-syrup-associated-names","referral_type":"Article 31 referrals","safety_referral":false,"procedure_number":"EMA/REF/0000355053","procedure_start_date":"2026-06-25","ec_decision_date":null,"verification":"official-publication","paid_placement":false,"source_id":"ema-medicines-json","source_url":"https://www.ema.europa.eu/en/medicines/human/referrals/rifadin-oral-suspension-syrup-associated-names","retrieved_at":"2026-10-17T20:21:43.732278+00:00"},{"id":"EMEA/H/C/005452","record_type":"medicine","category":"human","name":"Cibinqo","active_substance":"abrocitinib","inn":"abrocitinib","atc_code":"D11AH08","therapeutic_areas":["Dermatitis, Atopic"],"status":"Authorised","holder":"Pfizer Europe MA EEIG","published":"2021-12-17","updated":"2026-10-16","summary":"Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cibinqo","pharmacotherapeutic_group":"Other dermatological preparations","species":[],"flags":[],"authorisation_date":"2021-12-09","ec_decision_date":"2026-10-01","withdrawal_date":null,"verification":"official-publication","paid_placement":false,"source_id":"ema-medicines-json","source_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cibinqo","retrieved_at":"2026-10-17T20:21:43.732278+00:00","ongoing_shortage":false,"shortage_url":null,"dhpc_urls":[]}]}