SPA - SOCIETA PRODOTTI ANTIBIOTICI - S.p.a.
Modifiche secondarie di un'autorizzazione all'immissione in commercio
di specialita' medicinali per uso umano. (Comunicazioni Agenzia italiana del farmaco del 26 novembre 2007 (1 e 2) e 28 novembre 2007
(3)).
-
Codice pratica n. N1B/07/1036.
Specialita' medicinale: HYALART.,
Confezioni e numeri di A.I.C.:
"20 mg/2 ml soluzione iniettabile uso intra-articolare" 1 siringa preriempita 2 ml - A.I.C. n. 027663032;
"20 mg/2 ml soluzione iniettabile uso intra-articolare" 5 siringhe preriempite 2 ml - A.I.C. n. 027663044.
Modifica apportata ai sensi del regolamento 1084/2003/CE: n. 36.a - aggiunta al contenitore finale del prodotto finito, di un back stop in polipropilene per prevenire la fuoriuscita accidentale dello stantuffo durante l'aspirazione nella prima fase dell'iniezione.
-
Codice pratica n. N1B/07/1990.
Specialita' medicinale: SINARTROL.
Confezione e numero di A.I.C.:
"30 mg compresse" 20 compresse - A.I.C. n. 026396046.
Modifica apportata ai sensi del regolamento 1084/2003/CE: n. 37.b - aggiunta del parametro di prova "contaminazione microbica" alle specifiche del prodotto finito al termine del periodo di validita'.
-
Codice pratica n. NOT/2001/2834.
Specialita' medicinale: URACTONE.
Confezione e numero di A.I.C.:
"100 mg compresse" 10 compresse - A.I.C. n. 019408018.
Modifica apportata ai sensi del regolamento 1084/2003/CE: n. 23 - cambiamento...
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