COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio dei medicinali per uso umano «Lescol» e «Lipaxan». (15A04111)
Estratto determina V&A n. 892 /2015 del 13 maggio 2015 Sono autorizzate le seguenti variazioni: Aggiornamento del Riassunto delle caratteristiche del prodotto (paragrafi 2, 3, 4.4, 4.8), e della sez. 1-6 del Foglio Illustrativo, in accordo alla nuova versione del RMP. Aggiornamento in accordo al QRD Template, limitatamente all'aggiunta della frase prevista dal regolamento EU di Farmacovigilanza per la segnalazione degli effetti indesiderati. Adeguamento a PRAC Signal reccommendations ( 23 gennaio 2015), relativamente alle specialita' medicinali LESCOL e LIPAXAN, nelle seguenti forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di Procedura di Mutuo Riconoscimento: LESCOL (AIC 029163) 029163019 - "20 Mg Capsule Rigide" 28 Capsule In Blister Alu/Alu 029163021 - "40 Mg Capsule Rigide" 14 Capsule In Blister Alu/Alu 029163033 - "80 Mg Compresse Rilascio Prolungato" 28 Compresse In Blister Alu/Alu 029163045 - "40 Mg Capsule Rigide" 28 Capsule In Blister Alu/Alu 029163060 - " 80 Mg Compresse A Rilascio Prolungato " 42 Compresse In Blister Alu/Alu 029163072 - " 80 Mg Compresse A Rilascio Prolungato " 56 Compresse In Blister Alu/Alu 029163084 - " 80 Mg Compresse A Rilascio Prolungato " 98 Compresse In Blister Alu/Alu LIPAXAN (AIC 029199) 029199015 - "20 Mg Capsule Rigide" 28 Capsule In Blister Alu/Alu 029199027 - "40 Mg Capsule Rigide" 14 Capsule In Blister Alu/Alu 029199039 - "40 Mg Capsule Rigide" 28 Capsule In Blister Alu/Alu 029199041 - "80 Mg Compresse A Rilascio Prolungato" 28 Compresse In Blister Alu/Alu 029199066 - " 80 Mg Compresse A Rilascio Prolungato " 42 Compresse In Blister Alu/Alu 029199078 - " 80 Mg Compresse A Rilascio Prolungato " 56 Compresse In Blister Alu/Alu 029199080 - " 80 Mg Compresse A Rilascio Prolungato " 98 Compresse In Blister Alu/Alu Procedure: DE/H/xxxx/WS/206 - DE/H/xxxx/1A/702/G Tipologia delle variazioni: C.I.11 b) e C.I.z Titolare AIC: NOVARTIS EUROPHARM LTD Stampati 1. Il Titolare dell'Autorizzazione all'immissione in commercio deve apportare le modifiche...
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