COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Astumide». (14A10103)
Estratto della determina n. 1503/2014 del 16 dicembre 2014 Medicinale: ASTUMIDE Titolare AIC: Teva Italia S.r.l. - Via Messina, 38 - 20154 Milano Confezioni: "0,5 mg capsule molli" 10 capsule blister in PVC/PVDC/AL - AIC n. 043421015 (in base 10) 19F3BR (in base 32);
"0,5 mg capsule molli" 28 capsule blister in PVC/PVDC/AL - AIC n. 043421027 (in base 10) 19F3C3 (in base 32);
"0,5 mg capsule molli" 30 capsule blister in PVC/PVDC/AL - AIC n. 043421039 (in base 10) 19F3CH (in base 32);
"0,5 mg capsule molli" 50 capsule blister in PVC/PVDC/AL - AIC n. 043421041 (in base 10) 19F3CK (in base 32);
"0,5 mg capsule molli" 60 capsule blister in PVC/PVDC/AL - AIC n. 043421054 (in base 10) 19F3CY (in base 32);
"0,5 mg capsule molli" 90 capsule blister in PVC/PVDC/AL - AIC n. 043421066 (in base 10) 19F3DB (in base 32);
"0,5 mg capsule molli" 100 capsule blister in PVC/PVDC/AL - AIC n. 043421078 (in base 10) 19F3DQ (in base 32). Forma farmaceutica: capsule molli. Composizione: ogni capsula contiene: Principio attivo: 0,5 mg di dutasteride. Eccipienti: Contenuto delle capsule: Butilidrossitoluene (E321) Glicerolo monocaprylocaprate, Tipo I Capsula esterna: Gelatina (160 Bloom) Glicerolo (E422) Titanio diossido (E171) Ferro ossido giallo (E172) Altri componenti: Trigliceridi a media catena Paraffina liquida Acqua purificata Produzione principio attivo: MSN Laboratories Limited, Sy. No. 317 &
323, Rudraram (V), Patancheru (Mandal), Medak District, 502 329, Andhra Pradesh, India (produzione della sostanza attiva dutasteride) Hunan Yuxin Pharmaceutical Co., Ltd, Longxutang , Shaoyang 422001, Hunan, Cina (produzione dell'intermedio) Lucid Laboratories Pvt. Ltd., Plot No. 212, IDA Prashanthi Nagar, Kukatpaly, Hyderabad-500 072, India (sito di test per il contenuto di Palladio) DKR Labs., Plot No. 212, IDA Prashanthi Nagar, Kukatpaly, Hyderabad-500 072, India (sito di test per il contenuto di Palladio) Rilascio lotti: Teva Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen, Ungheria Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germania Controllo lotti: Teva Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen, Ungheria Merckle GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germania Produzione, confezionamento: Teva Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen, Ungheria (produzione e confezionamento) Indicazioni terapeutiche Trattamento dei sintomi da moderati a gravi dell'iperplasia...
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