COMUNICATO - Autorizzazione all''immissione in commercio del medicinale «Enapren» (09A13608)
Estratto determinazione AIC/N n. 2271 del 6 ottobre 2009
Descrizione del medicinale e attribuzione numero A.I.C. e autorizzata l'immissione in commercio del medicinale: ENAPREN, anche nella forma e confezione: «20 mg compresse» 28 compresse.
Titolare AIC: Merck Sharp e Dohme (Italia) S.p.a., con sede legale e domicilio fiscale in Roma, via G. Fabbroni n. 6 - cap 00191, codice fiscale 00422760587.
Confezione: «20 mg compresse» 28 compresse - A.I.C. n. 025682079 (in base 10) 0SHS4Z (in base 32).
Forma farmaceutica: compressa.
Validita' prodotto integro: trenta mesi dalla data di fabbricazione.
Produttore del principio attivo: MSD Quimica de Puerto Rico, Inc. Road # 2, km 56,7 Barceloneta PR (USA), MSD (Irlanda) Ballydine Kilsheelan, Clonmel CO Tipperary - Irlanda e MSD - Chibret Zone Industrielle De Blavozy Saint German Laprade - LA Vallee (Francia), BASF Orgamol Pharma Solutions SA (Svizzera).
Produttore del prodotto finito: MSD (Italia) S.p.a. stabilimento sito in Pavia, via Emilia n. 21 (completa); Neopharmed S.p.a. stabilimento sito in Bollate (Milano), via Pordoi n. 18 (confezionamento); MSD BV, Waarderweg 39, Haarlem Olanda (confezionamento).
Composizione: ogni compressa contiene:
principio attivo: enalapril maleato 20 mg;
eccipienti: sodio bicarbonato 10 mg; lattosio monoidrato 146,7 mg; amido di mais 20 mg; amido pregelatinizzato 2 mg; magnesio...
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