COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Donopa» (20A06049)
Estratto determina AAM/PPA n. 597/2020
Autorizzazione delle variazioni: sono autorizzate le seguenti variazioni relative alla specialita' medicinale DONOPA (A.I.C. n. 041095) nelle forme e confezioni autorizzate all'immissione in commercio:
C.I.z - modifiche ai paragrafi 4.6 e 6.6 del riassunto delle caratteristiche del prodotto relativamente all'esposizione in gravidanza e fertilita'. Rimozione della dicitura «gas esilarante»
C.I.3.a - modifiche ai paragrafi 4.4 e 4.8 del riassunto delle caratteristiche del prodotto per adeguamento alla procedura PSUSA/00010572/201706
C.I.3.a - modifica al paragrafo 4.8 del riassunto delle caratteristiche del prodotto per adeguamento alla procedura PSUSA/00010572/201806
paragrafi impattati dalla modifica: 2, 4.4, 4.6, 4.8, 5.3, 6.6, 8 del riassunto delle caratteristiche del prodotto e corrispondenti paragrafi del foglio illustrativo ed etichette
adeguamento all'ultima versione del QRD template e modifiche editoriali.
Titolare A.I.C.: Sol S.p.a.
Procedure europee: NL/H/2233/001/II/006 - NL/H/2233/001/IB/007 - NL/H/2233/001/IA/007.
Codici pratiche: VC2/2017/61 - C1B/2019/387 - C1A/2019/3224.
Gli stampati corretti ed approvati sono allegati alla determina di cui al presente estratto.
Stampati
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Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determina al riassunto delle caratteristiche del prodotto
entro e non oltre i sei mesi dalla medesima data al foglio illustrativo e all'etichettatura.
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In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e successive modificazioni ed integrazioni, il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella Provincia di Bolzano, anche in lingua tedesca. Il titolare dell'A.I.C. che intende avvalersi dell'uso complementare di lingue estere, deve darne preventiva comunicazione all'AIFA e...
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