COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Aciclovir Accord» (19A03502)
Estratto determina AMM/PPA n. 363/2019 del 7 maggio 2019 Autorizzazione variazione tipo II: e' autorizzata la variazione di tipo II B.II.d.1.e modifica dei parametri di specifica e/o dei limiti del prodotto finito - Modifica al di fuori dei limiti di specifica approvati: ampliamento dei limiti per le specifiche impurezza B e impurezze totali nel prodotto finito rispetto a quelli attualmente autorizzati al rilascio e alla shelf-life, relativamente al medicinale ACICLOVIR ACCORD nelle forme farmaceutiche/dosaggi e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura nazionale: A.I.C. n. 031846025 - «400 mg/5 ml sospensione orale» 1 flacone da 100 ml;
A.I.C. n. 031846037 - «5% crema» 1 tubo da 10 g;
A.I.C. n. 031846049 - «800 mg compresse» 35 compresse. Titolare A.I.C.: Accord Healthcare Limited con sede legale e domicilio in Sage House, 319, Pinner Road, North Harrow, HA1 4HF - Middlesex (Gran Bretagna)...
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