COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio del medicinale omeopatico «Belladonna Heel Complex». (20A02539)
Estratto determina AAM/AIC n. 40/2020 1. E' rinnovata l'autorizzazione all'immissione in commercio di cui all'art. 1, comma 590 della legge n. 190/2014 per il medicinale omeopatico BELLADONNA HEEL COMPLEX descritto in dettaglio nell'allegata tabella, composta da pagine 1, 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' Biologische Heilmittel Heel GmbH con sede legale e domicilio fiscale in Dr. Reckeweg-Straße 2-4, 76532 Baden-Baden (Germania). Stampati 1. Le confezioni del medicinale omeopatico 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. del medicinale omeopatico 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 legislativo devono essere redatte in lingua italiana e, limitatamente ai medicinali in commercio nella Provincia di Bolzano, anche in lingua tedesca. Il titolare del rinnovo dell'autorizzazione all'immissione in...
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