COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Cetiridie». (13A08891)
Estratto determinazione n. 920/2013 del 22 ottobre 2013 Medicinale: CETIRIDIE Titolare AIC: Johnson &
Johnson S.p.A. Via Ardeatina Km 23,500 00040 Santa Palomba Pomezia-Roma Confezione "10 mg capsule molli" 7 capsule in blister PVC/PE/PVDC AIC n. 042489017(in base 10) 18JP5T (in base 32) Forma farmaceutica: Capsule molli Composizione: Ogni capsula molle contiene: Principio attivo: 10 mg di cetirizina dicloridrato Eccipienti: Nucleo della capsula Macrogol 600 Potassio idrossido 43% w/w Povidone K30 Acqua purificata Rivestimento della capsula Gelatina Sorbitolo (E420) Glicerolo Acqua purificata Lecitina Trigliceridi a catena media Inchiostro nero Componenti dell'inchiostro nero per stampa. Glicole propilenico Ossido di ferro nero (E172) Polivinil acetato ftalato Macrogol 400 Idrossido di ammonio Produzione principio attivo: IPCA Laboratoires Limited k P.O. Sejavta India - 457 002 Ratlam Madhya Pradesh Produzione, controllo qualita' (BULK): Catalent Argentina S.A.I.C. Av Marquez 691 (B1657CSA) Villa Loma Hermosa Pcia.de Buenos Aires Argentina Confezionamento primario e secondario, controlo qualita', rilascio dei lotti: Catalent Germany Schorndorf Gmbh Steinbeisstr. 1 e 2 D-73614 Schorndorf Germany Controllo qualita' (qualita' microbiologica): BAV Insitute fuer Hygiene und Qualitatssicherung Hanns-Martin-Schleyer-Str. 25 77656 Offenburg Germany Confezionamento secondario: Springdew Limited Springdew Pharmaceuticals United 12 Woodlands Business Park Ystradynlais...
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