TEMAS - S.r.l.
Modifiche secondarie di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. (Comunicazione dell'Agenzia
italiana del farmaco del 21 settembre 2007). Codice pratica
N1A/07/1658.
Titolare A.I.C.: Temas S.r.l., via Albarella n. 1, 20019 Settimo Milanese (MI).
Specialita' medicinale: DESMOPPRESSINA TEMAS.
Confezioni e numeri di A.I.C.:
"0,1 mg compresse" 30 compresse - A.I.C. n. 036936019;
"0,2 mg compresse" 30 compresse - A.I.C. n. 036936021.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: n. 8.b.1: Aggiunta dell'officina Ferring GmbH, Wittland 11, P.O. Box 2145, D-24109 Kiel (Germany) per la fase di rilascio dei lotti di prodotto finito (escluso il controllo).
Comunicazione dell'Agenzia italiana del farmaco del 5 ottobre 2007. Codice pratica N1A/07/1830.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: n. 5: Modifica della ragione sociale dell'officina responsabile della produzione bulk, confezionamento primario e secondario, controlli chimici del prodotto finito da Ferring AB, con stabilimento sito in Soldattorpsvagen 5, SE-20061 Limhamn, Svezia a Rechon Life Science AB, con stabilimento sito in Soldattorpsvagen 5, SE-20061 Limhamn, Svezia.
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