COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Cialis» (24A01776)
Estratto determina IP n. 191 del 22 marzo 2024
Descrizione del medicinale da importare e attribuzione del numero di identificazione: al medicinale CIALIS 20 mg 4 compresse rivestite con film in blister uso orale autorizzato dall'European Medicines Agency - EMA e identificato con n. EU/1/02/237/003, sono assegnati i seguenti dati identificativi nazionali.
Importatore: Programmi sanitari integrati S.r.l. con sede legale in via Giovanni Lanza n. 3 - 20121 Milano.
Confezione:
Cialis
20 mg 4 compresse rivestite con film in blister uso orale - A.I.C. n. 051126011 (in base 10) 1JS7RV (in base 32)
Forma farmaceutica: compressa rivestita con film
Composizione: ogni compressa contiene:
principio attivo: 20 mg di tadalafil
Eccipienti: compressa: lattosio monoidrato, croscaramellosa sodica, idrossipropilcellulosa, cellulosa microcristallina, sodio laurilsolfato, magnesio stearato. Rivestimento con film: lattosio monoidrato, ipromellosa, triacetina, diossido di titanio (E171), ossido di ferro giallo (E172), talco.
Classificazione ai fini della rimborsabilita'
Cialis
20 mg 4 compresse rivestite con film in blister uso orale - A.I.C. n. 051126011
Classe di rimborsabilita': C
Classificazione ai fini della fornitura
Cialis
20 mg 4 compresse rivestite con film in blister uso orale - A.I.C. n. 051126011
RR - medicinale soggetto a prescrizione medica
Stampati
Le confezioni del medicinale importato devono essere poste in commercio con gli stampati conformi ai testi approvati dall'EMA con l'indicazione nella parte di pertinenza nazionale dei dati di identificazione di cui alla presente determina.
In ottemperanza all'art. 80 commi 1 e 3 del decreto legislativo 24 aprile 2006, n. 219 e successive modificazioni ed integrazioni il foglio illustrativo e le etichette devono...
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