CHIESI FARMACEUTICI S.P.A - 'Modifiche secondarie di un' AIC di medicinale per uso umano, apportate ai sensi del d.lgs.219/2006 e s.m.i.'
"Modifiche secondarie di un' AIC di medicinale per uso umano, apportate ai sensi del d.lgs.219/2006 e s.m.i." Titolare: Chiesi Farmaceutici S.p.a., via Palermo n. 26/A, 43122 Parma. Specialita' medicinale: MONOKET. Confezioni e numeri di A.I.C.: «20 mg compresse» 50 cpr - A.I.C. n. 025200015;
40 mg compresse
30 cpr - A.I.C. n. 025200027;
50 mg capsule a rilascio prolungato
30 cps - A.I.C. n. 025200039;
60 mg compresse a rilascio modificato
30 cpr - A.I.C. n. 025200041. «Ai sensi del regolamento CE 1234/2008 e della determinazione AIFA 18 dicembre 2009, si informa dell'avvenuta approvazione della seguente variazione». Codice pratica: N1B/2012/2626. Grouping di Variazioni Variazione tipo IB B.III.1.a) 2 - Presentazione di un certificato di conformita' alla Farmacopea Europea nuovo o aggiornato: Per una sostanza attiva (isosorbide-5-mononitrato) - Certificato di conformita' alla monografia corrispondente della Farmacopea europea - Certificato aggiornato presentato da un fabbricante gia' approvato (R1-CEP 1998-134-Rev 02). Variazione tipo IB B.III.1.a) 2 - Presentazione di un certificato di conformita' alla Farmacopea Europea nuovo o aggiornato: Per una sostanza attiva (isosorbide-5-mononitrato) - Certificato...
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