COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Pharepa» (11A03487)
Estratto determinazione V & A.N/ n. 327 del 25 febbraio 2011
Medicinale: PHAREPA.
Titolare A.I.C.: Pharmatex Italia S.r.l., con sede legale e domicilio fiscale in via Appiani, 22, 20121 - Milano - Codice Fiscale n. 03670780158.
Variazione A.I.C.: B.III.2.b Modifica al fine di conformarsi alla farmacopea europea o alla farmacopea nazionale di uno Stato membro - Modifica al fine di conformarsi ad un aggiornamento della monografia applicabile della farmacopea europea o della farmacopea nazionale di uno Stato membro.
Adeguamento Standard Terms.
L'autorizzazione all'immissione in commercio e' modificata come di seguito indicato:
E' autorizzata la modifica relativa all'adeguamento delle specifiche del principio attivo EPARINA SODICA alla pertinente monografia della Ph. Eur. edizione corrente:
Parte di provvedimento in formato grafico relativamente alle confezioni sottoelencate:
A.I.C. n. 034692018 - «25000 UI/5 ml soluzione iniettabile per uso endovenoso» 1 flacone da 5 ml
A.I.C. n. 034692020 - «25000 UI/5 ml soluzione iniettabile per uso endovenoso» 10 fiale da 5 ml
A.I.C. n. 034692032 - «5000 UI/ml soluzione iniettabile per uso sottocutaneo» 10 fiale da 1 ml
...
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