COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Duoplavin» (19A01262)
Estratto determina n. 87 del 12 febbraio 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: al medicinale DUOPLAVIN 75 mg/100 mg film-coated tablet - 28 tablets autorizzato dall'European Medicines Agency - EMA e identificato con n. EU/1/10/619/009, sono assegnati i seguenti dati identificativi nazionali. Importatore: GMM Farma S.r.l. con sede legale in via Lambretta 2 - 20090 Segrate (MI). Confezione: DUOPLAVIN «75 mg/100 mg - compressa rivestita con film - uso orale - blister (ALU/ALU)» 28 compresse. Codice A.I.C.: 047392016 (in base 10) 1F698J (in base 32). Forma farmaceutica: compressa rivestita con film. Ogni compressa rivestita con film contiene 75 mg di clopidogrel (come idrogenosolfato) e 100 mg di acido acetilsalicilico (ASA). Eccipienti: nucleo - mannitolo (E421), macrogol 6000, cellulosa microcristallina, idrossipropilcellulosa a basso grado di sostituzione, amido di mais, olio di ricino idrogenato, acido stearico, silice colloidale anidra;
rivestimento - lattosio monoidrato, ipromellosa (E464), titanio diossido (E171), triacetina (E1518), ferro ossido rosso (E172);
Agente lucidante - cera carnauba. Classificazione ai fini della rimborsabilita' Confezione: DUOPLAVIN «75 mg/100 mg - compressa rivestita con film - uso orale - blister (ALU/ALU)» 28 compresse. Codice A.I.C.: 047392016. Classe di rimborsabilita': «C(nn)». La confezione sopradescritta e' collocata in «apposita sezione» della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e...
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