COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Tachidol» (10A12144)
Estratto determinazione V & A.N/V n. 1931 del 24 settembre 2010
Medicinale: TACHIDOL.
Titolare AIC: Aziende Chimiche Riunite Angelini Francesco Acraf Spa (codice fiscale 03907010585) con sede legale e domicilio fiscale in viale Amelia, 70, 00181 - Roma - Italia.
Variazione AIC: Modifica stampati su richiesta ditta.
Si autorizza la modifica della dicitura da riportare sull'imballaggio esterno come di seguito riportata: «Medicinale soggetto alla disciplina del DPR 309/90: tabella II, sez. E - medicinale soggetto a prescrizione medica».
Relativamente alle confezioni sottoelencate:
AIC n. 031825019 - «Bambini 125 mg/5 ml + 7,5 mg/5 ml sciroppo» flacone da 120 ml;
AIC n. 031825033 - «Bambini 125 mg + 7,5 mg granulato effervescente» 10 bustine (sospesa).
I lotti gia' prodotti possono essere mantenuti in commercio fino alla...
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