ORGANON ITALIA - S.p.a.
Sede legale in Roma, via Ostilia n. 15
Capitale sociale Euro 5.720.000,00
Codice fiscale n. 00405640582
Modifica secondaria di un'autorizzazione all'immissione in commercio
di specialita' medicinale per uso umano. (Comunicazione Agenzia italiana del farmaco del 13 marzo 2006). Codice pratica: N1B/05/2080. Titolare: Organon Italia S.p.a., via Ostilia n. 15 - 00184 Roma. Specialita' medicinale: LANTANON. Confezioni e numeri di A.I.C.:
''30 mg compresse rivestite con film'' 30 compresse - A.I.C. n. 023695036;
''60 mg compresse rivestite con film'' 30 compresse - A.I.C. n. 023695051 (sospesa). Modifica apportata ai sensi del regolamento (CE) 1084/2003: 38. c Altre modifiche di una procedura di prova del prodotto finito, inclusa la sostituzione o l'aggiunta di una procedura di prova. Modifica del metodo TLC per l'identificazione del p.a. mianserina cloridrato e la determinazione delle sostanze correlate: da fase mobile cloroformio/metanolo (90:10 v/v) a fase mobile metilene cloruro/metanolo (90:10 v/v). Codice pratica: N1B/06/17. Specialita' medicinale: FILENA.
Titolare: Orion Corporation, Orionintie 1, FIN-02200 Espoo, Finlandia. Rappresentante in Italia: Organon Italia S.p.a., via Ostilia n. 15 - 00184 Roma. Confezioni e numeri di A.I.C.: ''compresse'' 21 compresse - A.I.C. n. 028758011; ''compresse'' 3 x 21 compresse - A.I.C. n. 028758023. Modifica apportata ai sensi del regolamento (CE) 1084/2003: 38. c Altre modifiche di una procedura di prova del prodotto finito, inclusa la sostituzione o l'aggiunta di una procedura di prova. Sostituzione del metodo TLC per l'identificazione dell'indigo carminio con metodo spettrofotometrico. Codice pratica: N1B/05/2120. Specialita' medicinale: PREGNYL.
Titolare: N.V. Organon, Kloosterstraat n. 6 - 5349 AB, Oss Olanda. Rappresentante in Italia: Organon Italia S.p.a., via Ostilia n. 15 - 00184 Roma. Confezioni e numeri di A.I.C.:
''1500 UI/1 ml polv. e solv. per soluzione iniettabile'' 3 fiale polv. 1500 UI + 3 fiale solv. 1 ml - A.I.C. n. 033717012;
5000 UI/1 ml polv. e solv. per soluzione iniettabile'' 3 fiale polv. 5000 UI + 3 fiale solv. 1 ml - A.I.C. n. 033717024. Modifica apportata ai sensi del regolamento (CE) 1084/2003: 38. c Altre...
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