COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Beriate». (20A03340)
Estratto determina AAM/PPA n. 323 del 12 giugno 2020 Si autorizza la seguente variazione: tipo II C.I.z) , approvazione del seguente inserimento nel foglio illustrativo al paragrafo «Questo prodotto medicinale e' autorizzato nei seguenti Stati membri della Comunita' europea con il nome»: [...] Estonia: Beriate;
Lettonia: Beriate 250 SV pulveris un šķīdinātājs injekciju vai infūziju šķīduma pagatavošanai;
Beriate 500 SV pulveris un šķīdinātājs injekciju vai infūziju šķīduma pagatavošanai;
Beriate 1000 SV pulveris un šķīdinātājs injekciju vai infūziju šķīduma pagatavošanai;
Beriate 2000 SV pulveris un šķīdinātājs injekciju vai infūziju šķīduma pagatavošanai;
Lituania: Beriate® 250 TV milteliai ir tirpiklis injekciniam ar infuziniam tirpalui;
Beriate® 500 TV milteliai ir tirpiklis injekciniam ar infuziniam tirpalui;
Beriate® 1000 TV milteliai ir tirpiklis injekciniam ar infuziniam tirpalui;
Beriate® 2000 TV milteliai ir tirpiklis injekciniam ar infuziniam tirpalui;
Polonia: Beriate 250;
Beriate 500;
Beriate 1000;
Beriate 2000. Modifiche dei paragrafi 1, 2 e 10 (quest'ultimo solo relativamente al dosaggio da 1000 U) delle etichette esterne. La suddetta variazione e' relativa al medicinale BERIATE, come da allegato alla determina (allegato 1) di cui al presente estratto, nelle forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. A.I.C. n.: 033657038 - «1000 ui/10 ml» flaconcino polvere + flaconcino solvente 10 ml + set accessori;
033657040 - «2000 ui/10 ml» flaconcino polvere + flaconcino solvente 10 ml + set accessori;
033657014 - «250 ui/2,5 ml» flaconcino polvere + flaconcino solvente 2,5 ml + set accessori;
03365026 - «500 ui/5 ml» flaconcino polvere + flaconcino solvente 5 ml + set accessori. Numero procedura: DE/H/0483/001-004/II/103. Codice pratica: VC2/2020/30. Titolare A.I.C.: CSL Behring GmbH. Stampati 1. I lotti del medicinale devono essere posti in...
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