COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Azilect» (24A01775)
Estratto determina IP n. 190 del 22 marzo 2024
Descrizione del medicinale da importare e attribuzione del numero di identificazione: al medicinale AZILECT 1 mg 28 compresse autorizzato dall'European Medicines Agency - EMA e identificato con n. EU/1/04/304/003, sono assegnati i seguenti dati identificativi nazionali.
Importatore: BB Farma S.r.l. con sede legale in viale Europa n. 160 - 21017 Samarate.
Confezione: AZILECT - «1 mg compressa - uso orale» blister ALU/ALU 28 compresse - codice A.I.C. n. 051125019 (in base 10) 1JS6SV
(in base 32).
Forma farmaceutica: compressa.
Composizione: ogni compressa contiene:
principio attivo: 1 mg di rasagilina
eccipienti: mannitolo, silice colloidale anidra, amido di mais, amido di mais pregelatinizzato, acido stearico, talco.
Classificazione ai fini della rimborsabilita'
Confezione: AZILECT - «1 mg compressa - uso orale» blister ALU/ALU 28 compresse - codice A.I.C. n. 051125019 - classe di rimborsabilita': Cnn.
Classificazione ai fini della fornitura
Confezione: AZILECT - «1 mg compressa - uso orale» blister ALU/ALU 28 compresse - codice A.I.C. n. 051125019 - 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 modifiche e integrazioni il foglio illustrativo e le etichette devono...
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