sabato, 5 ottobre 2024

Notizie AIOM – anno XVI n. 703

17 Dicembre 2018

12 dicembre 2018 – Comunicazione relativa a Pay-Back 5% 2018 – Importi I.V.A.

17 Dicembre 2018

13 dicembre 2018 – Biosimilari: prove di efficacia e real-world data ne confermano l’intercambiabilità

17 Dicembre 2018

13 dicembre 2018 – Modifiche indirizzi PEC e posta elettronica per il Settore HTA ed Economia del farmaco

17 Dicembre 2018

14 dicembre 2018 – Registri di Monitoraggio: Dose Flat Pembrolizumab (Merck Sharp & Dohme)

17 Dicembre 2018

14 dicembre 2018 – Comunicazione EMA su medicinali contenenti fosfomicina

17 Dicembre 2018

14 dicembre 2018 – Comunicazione EMA su medicinali contenenti metamizolo

17 Dicembre 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework

December 11, 2018 - Our public health obligations touch on many aspects of how medical products are developed and used by patients and providers. The bedrock of our mission is our consumer protection role – our obligation to protect patient safety. Part of our mission ...
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17 Dicembre 2018

FDA Approves Romiplostim for Pediatric ITP

December 14, 2018 - The FDA has approved romiplostim for the treatment of pediatric patients aged ≥1 year with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The approval ...
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17 Dicembre 2018

EU Panel Backs Maintenance Rucaparib for Ovarian Cancer

December 13, 2018 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended to expand the approval of single-agent rucaparib as a maintenance therapy in adult patients with platinum-sensitive relapsed high-grade epithelial ...
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17 Dicembre 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

December 14, 2018 - EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2018 meeting. Two orphan medicines1 received a positive opinion from the Committee: Ropeginterferon alfa-2b, for the treatment of polycythaemia vera ...
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