Galderma Italia - S.p.a.
Modifiche secondarie di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. (Comunicazioni Agenzia italiana del farmaco del 18 dicembre 2006). Codice pratica n.
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N1A/06/2016; codice pratica n. b) N1B/06/833; e del 24 gennaio 2007 - Codice pratica n. c) UPC/I/5621/2007.
Titolare: Galderma Italia S.p.a., sede legale: via dell'Annunciata n. 21, 20121 Milano, Uffici commerciali ed amministrativi: centro direzionale Colleoni, 20041 Agrate Brianza (MI).
Specialita' medicinale:
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STERADES, b) TETRALYSAL e c) METVIX.
Confezioni e numeri di A.I.C.
'a) 0,05 g/100 g soluzione cutanea', flacone da 60 ml - A.I.C. n. 033735061;
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'150 mg capsule rigide' 28 capsule rigide - A.I.C. n. 018469039;
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'160 mg/g crema' tubo da 2 g - A.I.C. n. 035995012/M.
Modifiche apportate ai sensi del regolamento (CE) n. 1084/2003 (legge 24.12.2003 n. 350):
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modifica secondaria tipo IA n. 36.b 'Modifica della forma o della dimensione del contenitore o della chiusura di altre forme farmaceutiche - modifica del tappo del confezionamento primario del prodotto finito da: tappo avvitato; a: tappo a scatto';
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modifica secondaria Tipo IB n. 25.a.1 'Modifica specifiche principio attivo precedentemente non inserita nella Farmac. eur. per ottemperare Farmac. eur. o a Farmac. naz. di Stato membro - modifica delle specifiche del principio attivo limeciclina, precedentemente non inserito nella Farmacopea europea per essere in conformita' alla Farmacopea europea';
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modifica secondaria Tipo IA n.7.a 'Sostituzione o aggiunta di un sito di produzione per imballaggio secondario...
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