COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Blissel» (14A05038)
Estratto determinazione V &
A n. 1189/2014 del 18 giugno 2014 Descrizione del medicinale e attribuzione n. A.I.C.: e' autorizzata l'immissione in commercio del medicinale: BLISSEL, nelle forme e confezioni: «50 microgrammi/g gel vaginale» tubo in AL da 10 g con 1 cannula riutilizzabile;
50 microgrammi/g gel vaginale
tubo in AL da 30 g con 1 cannula riutilizzabile;
in aggiunta alle confezioni gia' autorizzate, alle condizioni e con le specificazioni di seguito indicate. Titolare A.I.C.: Italfarmaco S.p.a., con sede legale e domicilio fiscale in Milano, viale Fulvio Testi, 330 - Cap 20126, Italia, codice fiscale 00737420158. Confezioni: «50 microgrammi/g gel vaginale» tubo in AL da 10 g con 1 cannula riutilizzabile - A.I.C. n. 040817037 (in base 10) 16XNDF (in base 32);
50 microgrammi/g gel vaginale
tubo in AL da 30 g con 1 cannula riutilizzabile - A.I.C. n. 040817049 (in base 10) 16XNDT (in base 32). Forma farmaceutica: gel vaginale. Composizione: 1 g di gel vaginale contiene: principio attivo: estriolo 50 mcg. Classificazione ai fini della rimborsabilita' Confezione: 040817037 - «50 microgrammi/g gel vaginale» tubo in AL da 10 g con 1 cannula riutilizzabile. Classe di 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 (nn)». Confezione: 040817049 - «50 microgrammi/g gel vaginale» tubo in AL da 30 g con 1 cannula riutilizzabile. Classe di 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 (nn)». Classificazione ai fini della fornitura Confezioni: 040817037 - «50 microgrammi/g gel vaginale» tubo in AL da 10 g con 1 cannula riutilizzabile - RNR...
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