COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Kaloba». (15A01436)
Estratto determina V&A n. 131/2015 del 28 gennaio 2015 E' autorizzata l'immissione in commercio del medicinale: KALOBA, anche nella forma e confezione: «20 mg/7,5 ml sciroppo» flacone da 100 ml con bicchiere dosatore, alle condizioni e con le specificazioni di seguito indicate. Titolare AIC: Dr. Willmar Schwabe GmbH &
Co. KG con sede legale e domicilio in Willmar Schwabe - Str. 4 - 76227 - Karlsruhe (Germania). Confezione: «20 mg/7,5 ml sciroppo» flacone da 100 ml con bicchiere dosatore. AIC n. 038135075 (in base 10) 14CT93 (in base 32). Forma farmaceutica: sciroppo. Validita' prodotto integro: 3 anni dalla data di fabbricazione. Produttore del principio attivo: Schwabe Extracta GmbH &
Co. KG, Willmar-Schwabe-Str.4 D-76227 - Karlsruhe - Germania. Produttore del prodotto finito: Dr. Willmar Schwabe GmbH &
Co. KG stabilimento sito in Karlsruhe - Germania, Willmar-Schwabe-Str.4, (produzione completa e rilascio lotti). Composizione: 100 g (= 93,985 ml) di sciroppo contengono: Principio attivo: estratto liquido essiccato delle radici di Pelargonium sidoides (1:8-10) 0,250 g L'agente estrattivo e' etanolo all'11% (w/w). Eccipienti: maltodestrina;
xilitolo;
glicerolo 85%;
acido citrico anidro;
potassio sorbato;
gomma xanthan;
acqua depurata. Indicazioni terapeutiche: Medicinale vegetale tradizionale indicato per l'attenuazione del raffreddore comune. L'impiego di questo medicinale vegetale tradizionale, per le indicazioni terapeutiche indicate, si basa esclusivamente sull'esperienza di utilizzo pluriennale. Classificazione ai fini della rimborsabilita' Confezione: AIC n. 038081042 - «20 mg/7,5 ml sciroppo» flacone da 100 ml con bicchiere dosatore. Classe di rimborsabilita': «C»...
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