COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Depo-Provera» (21A01199)
Estratto determina AAM/PPA n. 113/2021 del 19 febbraio 2021
Si autorizzano le seguenti variazioni: n. 2 variazioni tipo II C.I.4), modifica del paragrafo 5.1 del riassunto delle caratteristiche del prodotto per inserire nuove informazioni sulla densita' minerale ossea in adeguamento al Company core data sheet
(CCDS), con correzioni apportate dall'ufficio. Modifiche editoriali minori.
Le suddette variazioni sono relative al medicinale DEPO-PROVERA nelle forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura nazionale.
Confezioni e numeri di A.I.C.:
020329013 - «50 mg/ml sospensione iniettabile per uso intramuscolare» 1 flacone da 1 ml
020329025 - «50 mg/ml sospensione iniettabile per uso intramuscolare» 1 flacone da 5 ml
020329064 - «150 mg/ml sospensione iniettabile per uso intramuscolare» 1 flacone da 1 ml
020329076 - «150 mg/ml sospensione iniettabile per uso intramuscolare» 1 flacone da 3,4 ml
020329088 - «150 mg/ml sospensione iniettabile per uso intramuscolare» 1 flacone da 6,7 ml.
E' approvato il riassunto delle caratteristiche del prodotto allegato alla determina, di cui al presente estratto.
Codici pratiche: VN2/2016/381-VN2/2020/39.
Titolare A.I.C.: Pfizer Italia s.r.l. (codice fiscale n. 06954380157).
Stampati
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Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della determina al riassunto delle caratteristiche del prodotto, in conformita' al testo allegato alla determina di cui al presente estratto.
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In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e successive modificazioni ed integrazioni, il foglio illustrativo e...
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