COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Stronzio Ranelato Tecnigen» (16A03541)
Estratto determina n. 546/2016 del 20 aprile 2016 Medicinale: STRONZIO RANELATO TECNIGEN Titolare AIC: Tecnigen S.r.l. - Via Galileo Galilei, 40 - 20092 Cinisello Balsamo (MI), Italia Confezione AIC N. 044043014 - "2 g granulato per sospensione orale" 28 bustine in Carta/PE/Al Forma farmaceutica: Granulato per sospensione orale. Composizione: Ogni bustina contiene: Principio attivo: 2 g di stronzio ranelato. Eccipienti: Aspartame (E951) Maltodestrina Mannitolo (E421) Produzione principio attivo: Zhejiang Huahai Pharmaceutical Co., Ltd. (Chuannan Site) Chuannan, Duqiao, Linhai, Zhejiang, 317016, China Produzione, confezionamento, controllo lotti, rilascio lotti: Atlantic Pharma - Produções Farmacêuticas, S.A. Rua da Tapada Grande, nº2, Abrunheira 2710-089 Sintra, Portogallo Indicazioni terapeutiche: Trattamento dell'osteoporosi severa: - nelle donne in postmenopausa, - negli uomini adulti, ad alto rischio di fratture, per i quali il trattamento con altri medicinali approvati per la terapia dell'osteoporosi non sia possibile a causa, ad esempio, di controindicazioni o intolleranza. Nelle donne in postmenopausa, lo stronzio ranelato riduce il rischio di fratture vertebrali e dell'anca. La decisione di prescrivere lo stronzio ranelato deve essere basata su una valutazione dei rischi globali del singolo paziente. Classificazione ai fini della rimborsabilita' Confezione "2 g granulato per sospensione orale" 28 bustine in Carta/PE/Al AIC n. 044043014 (in base 10) 1B02S6 (in base 32) Classe di rimborsabilita': A (nota 79) Prezzo ex factory (IVA esclusa): €
16,75 Prezzo al pubblico (IVA inclusa): €
31,41 Sconto obbligatorio alle strutture pubbliche sul prezzo ex factory come da condizioni negoziali. Classificazione ai fini della fornitura La classificazione ai fini della fornitura del medicinale STRONZIO RANELATO TECNIGEN e' la seguente: Medicinale soggetto a prescrizione medica (RR). Condizioni e modalita' di impiego Prescrizione del medicinale...
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