TEVA ITALIA S.R.L. -
Modifiche secondarie di un'autorizzazione all'immissione in commercio di medicinali per uso umano. Modifiche apportate ai sensi del Regolamento 1234/2008/CE. Medicinale: ATORVASTATINA TEVA ITALIA, AIC n. 040234/M, in tutte le confezioni autorizzate, Codice Pratica C1B/2013/377, Grouping of variations n. UK/H/2900/01-04/IB/020/G, 2 Tipo IB foreseen n. A.2.b.: Modifica della denominazione del medicinale in Romania, da: Atilen a: Atorvastatina Teva , e in Repubblica Ceca da: Corat a: Atorvastatin ratiopharm GmbH. Medicinali: AZITROMICINA TEVA, AIC n. 037555/M e Azitromicina Teva Italia, AIC n. 038929/M in tutte le confezioni autorizzate;
Codice Pratica C1A/2013/533;
Grouping of variations NL/H/xxxx/IA/223/G;
1 Tipo IAin n. A.1.: Modifica dell'indirizzo del titolare AIC in Portogallo Teva Pharma - Produtos Farmaceuticos Lda da: Edificio Tejo, Rua Quinta do Pinheiro, N. 16, 6th, 2790 143 Carnaxide, Portogallo a: Lagoas Park, Edificio 5A, Piso 2, 2740-245 Porto Salvo, Portogallo e 2 Tipo IA n. A.7: Eliminazione dei siti di confezionamento primario e secondario : Teva Pharmaceuticals Industries Ltd, Hashikma St. Industrial Zone, P.O. Box 353, 44102 Kfar Saba, Israele e Teva Pharmaceuticals Industries Ltd, 2 Hamarpeh Street, P.O. Box 1142, 91010 Jerusalem, Israele. Medicinali: ALENDRONATO TEVA, AIC n. 037089/M in tutte le confezioni autorizzate;
Finasteride Dorom , AIC n. 040952/M in tutte le confezioni autorizzate;
Sotalolo Teva , AIC n. 035859/M in tutte le confezioni autorizzate;
Topiramato Teva, AIC n. 038974/M in tutte le confezioni autorizzate;
Grouping of variations n. DE/H/xxxx/IA/288/G, tipo IA n. A.5.b.: Modifica dell'indirizzo del produttore del prodotto finito, incluso confezionamento e controllo Teva Pharmaceuticals Industries Ltd da: 64 Hashikma St., Industrial Zone, P.O. Box 353, Kfar Saba, 44102 Israele a: 18 Eli Hurvitz Street, Industrial Zone, P.O. Box 353, Kfar Saba, 44102, Israele. Medicinale: CANDESARTAN E IDROCLOROTIAZIDE TEVA ITALIA, AIC n. 040868/M in tutte le confezioni autorizzate, Codice pratica: C1B/2013/548...
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