COMUNICATO - Autorizzazione della proroga scorte relativamente al medicinale per uso umano «Contramal». (14A08411)
Estratto determinazione V &
A n. 1926/2014 del 22 settembre 2014 Autorizzazione della proroga scorte relativamente al medicinale: «CONTRAMAL». Confezioni: AIC n. 028853012 - «50 mg capsule rigide» 20 capsule;
AIC n. 028853024 - «100 mg/ml gocce orali, soluzione con contagocce» flacone 10 ml;
AIC n. 028853036 - «100 mg compresse a rilascio prolungato» 20 compresse;
AIC n. 028853051 - «50 mg/ml soluzione iniettabile» 5 fiale 1 ml;
AIC n. 028853063 - «100 mg/2 ml soluzione iniettabile» 5 fiale 2 ml;
AIC n. 028853101 - «100 mg/ml soluzione orale con erogatore» 1 flacone 30 ml. Titolare AIC: Grunenthal Italia S.r.l. con sede legale e domicilio fiscale in via Vittor Pisani n. 16 - 20124 - Milano (MI) Italia - codice fiscale n. 04485620159. E' autorizzato, a decorrere dalla data di entrata in vigore della determinazione, di cui al presente estratto, il mantenimento in commercio delle confezioni gia' prodotte, fino alla data di scadenza del medicinale indicata in etichetta, previa consegna da parte dei farmacisti agli utenti, del foglio illustrativo aggiornato, ai sensi di quanto previsto dall'art. 1, commi 1, 2 e 3 della determinazione del Direttore Generale dell'AIFA concernente. «Criteri per l'applicazione delle disposizioni relative allo smaltimento delle scorte dei medicinali» n. 371 del 14/04/2014, adottata, in attuazione dell'art. 37 del decreto legislativo...
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