COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Parmodalin» (10A11532)
Estratta determinazione V & A.N/V n. 1721 del 9 settembre 2010
Titolare AIC: Laboratorio Farmaceutico SIT Specialita' igienico terapeutiche S.R.L. (codice fiscale 01108720598) con sede legale e domicilio fiscale in via Cavour, 70, 27035 - Mede (Pavia) Italia.
Medicinale: PARMODALIN.
Variazione AIC: modifica stampati su richiesta amministrazione.
E' autorizzata la modifica degli stampati (punti 4.4, 4.8 e 4.9 del RCP e corrispondenti paragrafi del foglio illustrativo), relativamente alla confezione sottoelencata:
A.I.C. n. 011531035 - «10 mg + 1 mg compresse rivestite» 25 compresse.
I lotti gia' prodotti non possono piu' essere...
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