EMA: Awiqli (Icodec) marketing authorisation the approval to market a medicine in one, several or all european union member states
03/06/2024
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Giallo
Le Breaking News di colore giallo sono relative a notizie dalle agenzie regolatorie o da società scientifiche: nuovi farmaci, ritiri, eventi avversi rilevanti…
EMA: Medical devices: new guidance for industry and notified bodies. Question-and-answer document clarifies regulatory requirements for devices used in combination with medicines
21/05/2024
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FDA: Tandem Diabetes Care, inc. recalls version 2.7 of the Apple IOS t:connect mobile app used in conjunction with t:slim x2 insulin pump with Control-IQ technology prompted by a software problem leading to pump battery depletion
08/05/2024
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AIFA – Gliptine (farmaci antidiabetici), primi farmaci riclassificati dalla classe A-PHT alla classe A: aggiornamento del Prontuario della continuità assistenziale ospedale-territorio (PHT)
13/05/2024
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AIFA – Farmaci per il trattamento del diabete mellito tipo 2: aggiornata la tabella B della Nota 100. Le modifiche introdotte sono successive all’aggiornamento dell’RCP di empagliflozin per quanto riguarda l’uso nella compromissione renale
17/04/2024
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EMA – GLP-1 receptor agonists: available evidence not supporting link with suicidal and self-injurious thoughts and actions
12/04/2024
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EMA – The Committee for Medicinal Products for Human Use (CHMP) for the medicinal product Nustendi adopted a new indication as follows: Cardiovascular disease
21/03/2024
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EMA – The Committee for Medicinal Products for Human Use (CHMP) for the medicinal product Nilemdo adopted a new indication as follows: Cardiovascular disease
21/03/2024
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