COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Mywy» (13A10212)
Estratto determinazione n. 1092/2013 del 2 dicembre 2013 Medicinale: MYWY. Titolare AIC: Zentiva Italia S.r.l., Viale Bodio, 37/B - 20158 Milano Confezione: "0,02 mg/3 mg compresse rivestite con film" 28 compresse in blister PVC/PVDC/AL - AIC n. 041346014 (in base 10) 17FSYY (in base 32) Confezione: "0,02 mg/3 mg compresse rivestite con film" 3×28 compresse in blister PVC/PVDC/AL - AIC n. 041346026 (in base 10) 17FSZB (in base 32) Confezione: "0,02 mg/3 mg compresse rivestite con film" 6×28 compresse in blister PVC/PVDC/AL - AIC n. 041346038 (in base 10) 17FSZQ (in base 32) Confezione: "0,02 mg/3 mg compresse rivestite con film" 13×28 compresse in blister PVC/PVDC/AL - AIC n. 041346040 (in base 10) 17FSZS (in base 32) Forma farmaceutica: Compressa rivestita con film. 24 compresse rivestite con film di colore rosa (compresse attive): Composizione: Ogni compressa rivestita con film contiene: Principio attivo: 0,02 mg di etinilestradiolo e 3 mg di drospirenone. 4 compresse rivestite con film di placebo (inattive): Composizione: Ogni compressa rivestita con film contiene: Principio attivo: La compressa non contiene principi attivi. Eccipienti: Compresse rivestite con film attive (rosa): Nucleo della compressa: Lattosio monoidrato Amido pregelatinizzato (mais) Povidone K-30 (E1201) Croscarmellosa sodica Polisorbato 80 Magnesio stearato (E572) Film di rivestimento della compressa: Polivinil alcol Titanio diossido (E171) Macrogol 3350 Talco Ossido di ferro giallo (E172) Ossido di ferro rosso (E172) Ossido di ferro nero (E172) Compresse rivestite con film di placebo (bianche): Nucleo della compressa: Lattosio anidro Povidone (E1201) Magnesio stearato (E572) Film di rivestimento della compressa: Polivinil alcol Titanio diossido (E171) Macrogol 3350 Talco Produzione principio attivo: Etinilestradiolo N. V. Organon 1) Veersemeer 4 5347 JN Oss - Olanda 2) Kloosterstraat 6 5349 AB Oss - Olanda Drospirenone Industriale Chimica S.r.l., Via E.H. Grieg, 13;
21047 Saronno (Varese) - Italia Quimica Sintetica S.A. - C/Dulcinea S/N - 28805 Alcala De Henares, Madrid - Spagna Produzione, confezionamento primario e secondario, controllo e rilascio...
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