COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Ceftriaxone Mylan Generics». (19A01881)
Estratto determina AAM/PPA n. 209/2019 del 6 marzo 2019 Autorizzazione delle variazioni: B.II.b.2.c.2), B.II.d.1.a) B.II.d.1.c) B.II.d.1.d) B.II.e.1.b.2) B.II.b.1.a) B.II.b.1.z) B.II.b.2.a): aggiunta del sito di produzione del prodotto finito, confezionamento primario e confezionamento secondario: Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd No. 16, Lanqing Yilu, Hi-Tech Zone, Guanlan, Longhua New District, Shenzhen, Guangdong, 518110 - China;
aggiunta del sito responsabile del controllo qualita' (solo microbiologico: endotossine batteriche e sterilita'): Pharmavalid Ltd, 1136, Budapest, Tatra utca 27 /b - Hungary;
aggiunta del sito responsabile del controllo qualita' (eccetto microbiologico) e rilascio dei lotti: Wessling Hungary Kft. Foti ut 56 1047 Budapest - Hungary;
aggiunta del Batch Size del medicinale «Ceftriaxone Mylan Generics» (Ceftriaxone 1,0 g) prodotto presso il sito: Sinopharm Zhijun (Shenzen) Pharmaceutical Co., Ltd - China, da 42,000 a 150,000 fiale;
aggiunta del Batch Size del medicinale «Ceftriaxone Mylan Generics» (Ceftriaxone 2,0 g) prodotto presso il sito: Sinopharm Zhijun (Shenzen) Pharmaceutical Co., Ltd - China, da 5,000 a 40,000 fiale;
aggiunta del saggio delle «visible particles» al rilascio dei lotti ed in stabilita' in accordo alla monografia generale di Ph. Eur. 2.9.20;
aggiunta del saggio della «specific optical rotation» al rilascio dei lotti ed in stabilita' in accordo alla monografia della sostanza attiva;
eliminazione del saggio dell'uniformita' di dosaggio (Ph. Eur. 2.9.40) al rilascio dei lotti ed in stabilita';
rafforzamento dei limiti del saggio del «water content» al rilascio dei lotti ed in stabilita' (8,0-11,0%) per...
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