COMUNICATO - Autorizzazione all''immissione in commercio del medicinale «Okitask» (12A09819)
Estratto determinazione V & A. n. 1251 del 5 settembre 2012
Descrizione del medicinale e attribuzione n. A.I.C.: e' autorizzata l'immissione in commercio del medicinale «OKITASK», nelle forme e confezioni: «40 mg granulato» 10 bustine; «40 mg granulato» 20 bustine con le specificazioni di seguito indicate, a condizione che siano efficaci alla data di entrata in vigore della presente determinazione:
titolare A.I.C.: Dompe' S.p.A. con sede legale e domicilio fiscale in 67100 - L'Aquila, via Campo Di Pile s.n.c., codice fiscale n. 01241900669.
Confezione: «40 mg granulato» 10 bustine - A.I.C. n. 042028011 (in base 10) 182LZC (in base 32).
Forma farmaceutica: granulato.
Validita' prodotto integro: 2 anni dalla data di fabbricazione.
Produttore del principio attivo: Bidachem stabilimento sito in Fornovo S. Giovanni (Bergamo) strada statale 11 e SIMS S.r.l. soc. Italiana Medicinali stabilimento sito in Scandicci loc. Filarone - Reggello (Firenze).
Produttore del prodotto finito:
Dompe' S.p.A. stabilimento sito in via Campo Di Pile s.n.c. - L'Aquila (produzione completa a partire dall'intermedio rivestito);
Micro-Sphere SA stabilimento sito in Svizzera, Madonna del Piano - CH (intermedio rivestito).
Composizione: 1 bustina di granulato contiene:
principio attivo: Ketoprofene sale di lisina 40 mg (corrispondente a 25 mg di Ketoprofene); eccipienti: Povidone; Silice colloidale; Idrossimetilcellulosa; Eudragit EPO; Sodio dodecil solfato; Acido stearico; Magnesio stearato; Aroma lime; Aroma limone; Aroma frescofort; Aspartame; Mannitolo; Xilitolo; Talco.
Confezione: «40 mg granulato» 20 bustine - A.I.C. n. 042028023 (in base 10) 182LZR (in base 32).
Forma farmaceutica: granulato.
Validita' Prodotto Integro: 2 anni dalla data di fabbricazione.
Produttore del principio attivo: Bidachem stabilimento sito in Fornovo S. Giovanni (Bergamo) strada statale 11 e SIMS S.r.l. soc. Italiana Medicinali stabilimento sito in Scandicci loc. Filarone - Reggello (Firenze).
Produttore del prodotto finito: Dompe' s.p.a. stabilimento sito in via Campo Di Pile s.n.c. -L'Aquila...
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