PFIZER ITALIA S.R.L. - Modifiche secondarie di un'AIC di medicinale per uso umano, apportata ai sensi del d.lgs. 219/2006 e s.m.i.
Modifiche secondarie di un'AIC di medicinale per uso umano, apportata ai sensi del d.lgs. 219/2006 e s.m.i. Ai sensi della Determinazione AIFA 25 agosto 2011 si informa dell'avvenuta approvazione delle seguenti modifiche apportate in accordo al regolamento (CE) 1234/2008: Specialita' medicinale: ZITROMAX Confezioni e numeri di AIC: 500mg polvere per soluzione per infusione AIC n. 027860156 Codice pratica: N1B/2012/2256 Titolare AIC: Pfizer Italia S.r.l. - Via Isonzo, 71 - 04100 Latina Variazione tipo IB - B.II.b.1.f - Aggiunta sito produzione bulk e confezionamento primario: Pharmacia &
Upjohn Company, 7000 Portage Road - Kalamazoo, Michigan (USA) Specialita' medicinale: DALACIN C Confezioni e numeri di AIC: Capsule rigide 150mg AIC n. 022633059 Capsule rigide 300mg AIC n. 022633085 Codice pratica: N1A/2012/2191 Titolare AIC: Pfizer Italia S.r.l. - Via Isonzo, 71 - 04100 Latina Variazione Grouping 2 Tipo IA: B.III.1.a.2 - Aggiornamento CEP clindamicina cloridrato da produttore gia' autorizzato (Carelife) R1-CEP 2000-210-Rev. 01;
A.7 - Eliminazione sito produzione principio attivo: Pfizer Pharmaceuticals LLC - Arecibo, Porto Rico Specialita' medicinale: DALACIN T Confezioni e numeri di AIC: 1% soluzione cutanea - flacone 30ml AIC n. 025314016 1% emulsione cutanea - flacone 30ml AIC n. 025314030 1% gel - tubo 30g AIC n. 025314042 Titolare AIC: Pfizer Italia S.r.l. - Via Isonzo, 71 - 04100 Latina Codice pratica: N1A/2012/2128 A.7 - Tipo IA Eliminazione sito produzione principio attivo: Pfizer Pharmaceuticals LLC - Arecibo, Porto Rico Specialita' medicinale: ESTRACYT Confezioni e numeri di AIC: 140mg capsule rigide, 40 capsule AIC n. 024397010 140mg capsule rigide, 100 capsule AIC n. 024397022 Codice pratica: N1A/2012/2232 Titolare AIC: Pfizer Italia S.r.l. - Via Isonzo, 71 - 04100 Latina Variazione B.II.a.1.a - Tipo IAIN -...
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