COMUNICATO - Integrazione della determina AAM/AIC n. 227 del 6 dicembre 2019, concernente il rinnovo dell'autorizzazione all'immissione in commercio di taluni medicinali omeopatici, relativamente al medicinale «Cyclamen Europaeum». (20A01430)
Estratto determina AAM/A.I.C. n. 30 del 18 febbraio 2020 1. E' rinnovata l'autorizzazione all'immissione in commercio per il medicinale omeopatico CYCLAMEN EUROPAEUM per le confezioni: A.I.C. n. 047799679 - «050 LM granuli» 1 contenitore monodose in PP da 1 g;
A.I.C. n. 045599681 - «060 LM granuli» 1 contenitore monodose in PP da 1 g, descritte in dettaglio nell'allegata tabella, composta da quattro pagine, che costituisce parte integrante della presente determina, alle condizioni e con le specificazioni ivi indicate. 2. Il titolare dell'autorizzazione all'immissione in commercio e' Hering S.r.l. con sede legale e domicilio fiscale in viale dello Sviluppo n. 6 - contrada Fargione - zona industriale - 97015 Modica (RG). Stampati 1. Le confezioni dei medicinali di cui all'art. 1 della presente determina devono essere poste in commercio con le etichette e, ove richiesto, con il foglio illustrativo, conformi ai testi allegati alla presente determina e che costituiscono parte integrante della stessa. 2. Resta fermo l'obbligo in capo al titolare del rinnovo dell'autorizzazione all'immissione in commercio di integrare le etichette e il foglio illustrativo con le sole informazioni relative alla descrizione delle confezioni ed ai numeri di A.I.C. dei medicinali omeopatici oggetto di rinnovo con la presente determina. 3. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219, e successive modificazioni le indicazioni di cui agli articoli 73, 77 e 79 del medesimo decreto...
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