COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Feanolla» (13A10204)
Estratto determinazione n. 1114/2013 del 2 dicembre 2013 Medicinale: FEANOLLA. Titolare AIC: Lupin (Europe) Limited Victoria Court Bexton Road Knutsford Cheshire WA16 0PF Regno Unito Confezione: «75 microgrammi compresse rivestite con film» 28 (1x28) compresse in blister PVC/AL - AIC n. 041781016 (in base 10) 17V1SS (in base 32). Confezione: «75 microgrammi compresse rivestite con film» 84 (3x28) compresse in blister PVC/AL - AIC n. 041781028 (in base 10) 17V1T4 (in base 32). Confezione: «75 microgrammi compresse rivestite con film» 168 (6x28) compresse in blister PVC/AL - AIC n. 041781030 (in base 10) 17V1T6 (in base 32). Forma farmaceutica: Compressa rivestita con film. Composizione: Ogni compressa rivestita con film contiene: Principio attivo: 75 microgrammi di desogestrel. Eccipienti: Nucleo della compressa: Lattosio monoidrato All rac α
Tocoferolo (E307) Povidone K30 Silice colloidale anidra Talco (E553b) Amido di mais Acido stearico Magnesio stearato (E470b) Film di rivestimento: Ipromellosa (HPMC2910, E464) Diossido di titanio (E171) Macrogol 400 (PEG 400) Produzione del principio attivo: Lupin Limited Plot No.2, SEZ Phase II, Pithampur (Dist. Dhar), Indore 454 774 (Madhya Pradesh State), India Produzione: Lupin Limited Plot No. 2, SEZ Phase - II, Pithampur - Dist.: Dhar, Indore 454774, Madhya Pradesh, India. Confezionamento primario e secondario: Lupin Limited Plot No. 2, SEZ Phase - II, Pithampur - Dist.: Dhar, Indore 454774, Madhya Pradesh, India. Confezionamento secondario: Hormosan Pharma GmbH Wilhelmshöher Str. 106, D-60389, Frankfurt/Main, Germania Controllo di qualita': Exova (UK) Limited Lochend Industrial Estate, Newbridge, Midlothian, EH28 8PL, Regno Unito International Laboratory Services Limited (ILS) London Road, Shardlow Business Park, Shardlow, Derby, Derbyshire, DE72 2GD, Regno Unito Select Pharma Laboratories Limited 55 Stirling Enterprise Park, Stirling, FK7 7RP, Regno Unito Select Bio Laboratories Limited Biocity Scotland, Bo'ness Road, Motherwell, Lanarkshire, ML1 UH, Regno Unito Rilascio...
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