COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Sodio Cloruro Galenica Senese». (19A04513)
Estratto determina AAM/PPA n. 531 del 26 giugno 2019 E' autorizzata l'immissione in commercio del medicinale SODIO CLORURO GALENICA SENESE, anche nelle forme e confezioni di seguito indicate: confezioni: «0,9% soluzione per infusione» 1 flaconcino in pp da 250 ml;
A.I.C. n. 029874575 (in base 10) 0WHQDH (in base 32). «0,9% soluzione per infusione» 30 flaconcini in pp da 250 ml;
A.I.C. n. 029874587 (in base 10) 0WHQDV (in base 32). Forma farmaceutica: soluzione per infusione. Principio attivo: sodio cloruro. Sono inoltre autorizzate le variazioni B.II.e.4.c), B.II.b.4.b), e B.II.e.5.a.2);
Codice pratica: N1B/2017/958. Titolare A.I.C.: Industria Farmaceutica Galenica Senese S.r.l. (codice fiscale 00050110527) con sede legale e domicilio fiscale in Via Cassia Nord, 351, 53014 - Monteroni D'Arbia - Siena (SI) Italia. Classificazione ai fini della rimborsabilita': per le confezioni di cui all'art. 1 e' adottata la seguente classificazione ai fini della rimborsabilita': apposita sezione della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, dedicata ai farmaci non ancora valutati ai fini della rimborsabilita', denominata classe C;
Classificazione ai fini della fornitura: per la confezione «0,9% soluzione per infusione» 1 flaconcino in pp da 250 ml e' adottata la seguente classificazione ai fini della fornitura: SOP medicinale non soggetto a prescrizione medica ma non da banco;
per la confezione «0,9% soluzione per infusione» 30 flaconcini in pp da 250 ml e' adottata la seguente classificazione ai...
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