ISTITUTO CHIMICO INTERNAZIONALE DR. GIUSEPPE RENDE S.R.L. - Modifica secondaria di un'autorizzazione all'immissione in commercio di un medicinale per uso umano, apportata ai sensi del regolamento 1234/2008/ CE
Modifica secondaria di un'autorizzazione all'immissione in commercio di un medicinale per uso umano, apportata ai sensi del regolamento 1234/2008/ CE Titolare A.I.C.: Istituto Chimico Internazionale Dr. Giuseppe Rende S.r.l. Ai sensi della Determinazione AIFA del 25 agosto 2011, si informa dell'avvenuta approvazione delle seguenti variazioni: Specialita' medicinale: LEMAXIL nei seguenti dosaggi e confezioni: «250 mg compresse rivestite con film», 5 compresse - A.I.C. n. 040048011;
500 mg compresse rivestite con film
, 5 compresse - A.I.C. n. 040048023. Codice pratica: N1A/2012/2278. Tipologia della variazione: Grouping costituito da 3 variazioni relative al prodotto finito: Tipo IA - B.I.b.1 Change in the specification parameters and/or limits or an active substance, starting material /...
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