COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Niaouli Essenza Zeta». (20A03437)
Estratto determina AAM/PPA n. 338/2020 del 19 giugno 2020 Autorizzazione del grouping di variazioni, descrizione del medicinale, attribuzione nuovi numeri A.I.C., in sostituzione delle confezioni precedentemente autorizzate. E' autorizzato il seguente grouping di variazioni: B.II.a.3 b) 6) - B.II.a.3.z) - B.II.b.2) c) 2) - B.II.b.4. a) - B.II.e.4.a) - B.II.e.5.d) - B.II.f.1.a.1). Modifica della batch formula del prodotto finito, eliminazione della miscela antiossidante dalla stessa formulazione, riduzione del periodo di validita' del medicinale da cinque a tre anni. Aggiunta di un ulteriore sito di controllo (eccetto per analisi microbiologiche) e rilascio lotti: Azienda Marco Viti Farmaceutici S.p.a, gia' autorizzata per la produzione e il confezionamento di entrambi i dosaggi autorizzati. Modifica dei batch size: 50 e 180 kg per il dosaggio 1% e un unico batch size, 180 kg, per il dosaggio 2%. L'immissione in commercio del medicinale NIAOULI ESSENZA ZETA (AIC 031347) e' autorizzata anche nelle forme farmaceutiche, dosaggi e confezioni di seguito indicate: Confezioni: «1% bambini gocce nasali, soluzione» flacone in vetro da 10 g con contagocce A.I.C. 031347038 (base 10) 0XWNBY (base 32);
che sostituisce la confezione precedentemente autorizzata: A.I.C. 031347014 - «1% bambini gocce nasali soluzione» flacone da 20 ml;
2% adulti gocce nasali, soluzione
flacone in vetro da 20 g con contagocce A.I.C. 031347040 (base 10) 0XWNC0 (base 32);
che sostituisce la confezione precedentemente autorizzata: A.I.C. 031347026 - «2% adulti gocce nasali soluzione» flacone da 20 ml. Forma farmaceutica: gocce nasali, soluzione. Principio attivo: niaouli essenza (olio gomenolato). Titolare A.I.C.: Zeta Farmaceutici S.p.a. Codice pratica: N1B/2020/52. Classificazione ai fini della rimborsabilita' Per le confezioni di cui all'art. 1 e' adottata la seguente classificazione ai fini della rimborsabilita': Classificazione: classe C. Classificazione ai fini della fornitura Per le...
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