COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Alabaster» (19A04006)
Estratto determina AAM/PPA n. 450 del 3 giugno 2019 Autorizzazione delle variazioni: variazioni di tipo II: C.I.4) una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati sulla qualita', preclinici, clinici o di farmacovigilanza, C.I.z) e C.I.3.z), relativamente al medicinale ALABASTER. Numeri di procedura: DE/H/0874/002/II/053;
DE/H/0874/002/II/052G;
DE/H/0874/002/II/054G;
DE/H/0874/002/II/055G. E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto alle sezioni 4.4 e 4.8, e corrispondenti paragrafi del foglio illustrativo, e delle etichette per adeguamento al QRD template, relativamente al medicinale ALABASTER, nelle forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. E' inoltre autorizzata, per adeguamento agli standard terms, la modifica della descrizione delle seguenti confezioni da: A.I.C. n. 037776034 «100 microgrammi/6 microgrammi polvere per inalazione» 1 inalatore in ABS/PP da 120 dosi;
a: A.I.C. n. 037776034 «100 microgrammi/6 microgrammi per inalazione polvere per inalazione» 1 inalatore in ABS/PP da 120 dosi;
da: A.I.C. n. 037776046 «100 microgrammi/6 microgrammi polvere per inalazione» 2 inalatori in ABS/PP da 120 dosi;
a: A.I.C. n. 037776046 «100 microgrammi/6 microgrammi per inalazione polvere per inalazione» 2 inalatori in ABS/PP da 120 dosi ciascuno;
da: A.I.C. n. 037776059 «100 microgrammi/6 microgrammi polvere per inalazione» 3 inalatori in ABS/PP da 120 dosi;
a: A.I.C. n. 037776059 «100 microgrammi/6 microgrammi per inalazione polvere per inalazione» 3 inalatori in ABS/PP da 120 dosi ciascuno. Gli stampati corretti ed approvati sono allegati alla determina, di cui al presente estratto. Titolare A.I.C.: Master Pharma S.r.l., con sede legale e domicilio fiscale in Parma, via Giacomo Chiesi n. 1 - C.A.P. 43122 (Italia), codice fiscale 00959190349. Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determina al...
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