COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Capecitabina Sandoz». (15A08021)
Estratto determina V&A n. 1975/2015 del 14 ottobre 2015 Procedura EU n. NL/H/2458/001-002/II/017 Medicinale: CAPECITABINA SANDOZ Tipo II: B.I.z E' autorizzata la seguente variazione: Aggiornamento del Active Substance Master File dalle versioni AP/v02-00 /2012-03 &
Amendment AP/v02-01 /2013-07 e RP/ v00-00/ 2012-03 &
Amendment RP/ v00-001/ July 2013 alle seguenti versioni: Applicant Part AP/v03-00 /2014-04;
Restricted Part RP/ v01-00/ 2014-04 Titolare AIC: SANDOZ S.P.A. (Codice fiscale 00795170158) Smaltimento scorte I lotti gia' prodotti possono essere mantenuti in commercio fino alla data...
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