TAKEDA ITALIA FARMACEUTICI - S.p.a.
Modifica secondaria di un'autorizzazione alla immissione
in commercio di specialita' medicinale per uso umano
Titolare: Takeda Italia Farmaceutici S.p.a., V. E. Vittorini n. 129, Roma.
Specialita' medicinale: LANSOX 15 mg e 30 mg capsule e compresse.
Confezione e numero di A.I.C.: tutti.
Comunicazione Agenzia italiana del farmaco del 25 ottobre 2007. Codice pratica N1A/07/1526.
Modifica apportata ai sensi del regolamento CE n. 1084/2003: Var. tipo IA n. 13a Modifica minore di una procedura di prova apportata: modifica minore del metodo di cromatografia liquida impiegato per la determinazione del titolo del principio attivo.
Comunicazione Agenzia italiana del farmaco del 25 ottobre 2007. Codice pratica N1A/07/1527.
Modifica apportata ai sensi del regolamento CE n. 1084/2003: Var. tipo IA n. 13a "Modifica minore di una procedura di prova apportata: modifica minore del metodo di cromatografia liquida impiegato per la determinazione delle sostanze correlate nel principio attivo.
Comunicazione Agenzia italiana del farmaco del 25 ottobre 2007. Codice pratica N1A/07/1528.
"Modifica, apportata ai sensi del regolamento CE n. 1084/2003: Var. tipo IA n. 13a Modifica minore del metodo impiegato per la determinazione del contenuto di acqua del principio attivo.
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