COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Atorvastatina Germed Pharma» (13A03321)
Estratto determinazione n. 339/2013 del 29 marzo 2013 Medicinale: ATORVASTATINA GERMED PHARMA. Titolare A.I.C.: Germed Pharma S.p.A. - via Cesare Cantu', 11 - 20092 Cinisello Balsamo (MI) - Italia. Confezione: «80 mg compresse rivestite con film» 30 compresse in blister AL/OPA/PVC/AL - A.I.C. n. 040665073/M (in base 10) 16SZZK (in base 32). Forma farmaceutica: compressa rivestita con film. Composizione: ogni compressa rivestita con film contiene: principio attivo: 80 mg di atorvastatina come atorvastatina calcio triidrato;
eccipienti: nucleo della compressa: cellulosa microcristallina, crospovidone tipo A, sodio carbonato anidro, povidone, glicerolo dibeenato, magnesio stearato;
film di rivestimento: ipromellosa 6 CP, titanio diossido (E171), macrogol 6000. Produzione, confezionamento primario e secondario, controllo, rilascio: Actavis hf. Reykjavikurvegur - 76 - 78, 220 Hafnarfjørður - Islanda. Confezionamento secondario: S.C.F. S.N.C. Di Giovenzana Roberto e Pelizzola Mirko Claudio - Via F. Barbarossa, 7, 26824 Cavenago d'Adda (LO) - Italia. Produzione principio attivo: Biocon Limited - site1c/o 20th K.M. - Hosur Road, Electronics City, Bangalore-560100;
site2 c/o Biocon Special Economic Zone, Plot N.2-4, Phase IV, Bommasandra-Jigani Link Road, Bommasandra Post, Bangalore-560099 - India. Indicazioni terapeutiche: ipercolesterolemia: Atorvastatina Germed Pharma e' indicato in aggiunta alla dieta per ridurre i livelli elevati di colesterolo totale, (C-totale) colesterolo LDL (C-LDL), apolipoproteina B, e trigliceridi in pazienti adulti, in adolescenti e bambini di 10 anni ed oltre affetti da ipercolesterolemia primaria, inclusa ipercolesterolemia familiare (variante eterozigote) o iperlipidemia combinata (mista) (corrispondente ai Tipi IIa e IIb della classificazione di Frederickson) quando la risposta alla dieta e ad altre misure non farmacologiche sono inadeguate;
Atorvastatina Germed Pharma e' anche indicato per ridurre il colesterolo totale ed il colesterolo LDL in pazienti adulti con ipercolesterolemia familiare omozigote in aggiunta ad altri trattamenti ipolipemizzanti (per esempio, LDL aferesi) o se tali trattamenti non...
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