ratiopharm Italia - S.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio di una specialita' medicinale per uso umano. (Modifica apportata ai sensi del decreto legislativo 29 dicembre 2007, n. 274 - Modifica apportata ai sensi del regolamento 1084/2003/CE).
Medicinale: ACICLOVIR ratiopharm Italia.
Confezioni e numeri di A.I.C.: 033063025 '800 mg compresse' 35 compresse.
Modifica Tipo IB n. 37b e conseguente n. 38c Aggiunta di un nuovo parametro di prova ed aggiunta della procedura di prova 'dissolution test'.
Medicinale: LORMETAZEPAM ratiopharm Italia.
Confezioni e numeri di A.I.C.: 036078018 '2,5 mg/ml' 20 ml gocce orali.
Variazione Tipo IA n. 9 Eliminazione del sito di produzione del prodotto finito Consorzio Farmaceutico e Biotecnologico Bioprogress S.c. a r.l.
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