BONISCONTRO E GAZZONE - S.r.l.
Sede Legale: in I-20136-Milano,Via Pavia,6
Codice Fiscale e/o Partita IVA: Codice Fiscale n. 8205300588
Modifiche secondarie di un'autorizzazione all'immissione in commercio di specialita' medicinali per uso umano. Comunicazioni Agenzia Italiana del Farmaco del 09 febbraio 2007
Titolare: Boniscontro e Gazzone Srl, Via Pavia 6- I-20136-Milano
Specialita' Medicinale: DOLGOSIN
Codice pratica: N1B/06/1462
Numeri A.I.C. e Confezioni: 034925014 - '100 mg capsule rig.ril. prol.', 6 cps; 034925026 - '100 mg capsule rig.ril. prol ', 56 cps; 034925038 - '200 mg capsule rig.ril. prol ', 3 cps; 034925040 - '200 mg capsule rig.ril. prol ', 28 cps.
Modifica apportata ai sensi del Regolamento (CE) 1084/2003: n.38c: Altre modifiche di una procedura di prova del prodotto finito, inclusa la sostituzione o l'aggiunta di una procedura di prova - Autorizzata.
Specialita' Medicinale: SERTRALINA BONISCONTRO E GAZZONE
Codice pratica: N1B/07/68
Numeri A.I.C. e Confezioni : 036803 - In tutte le confezioni.
Modifica apportata ai sensi del Regolamento (CE) 1084/2003: n.42a1: Modifica validita' del prod.finito come confezionato per la vendita - da 1 anno a 2 anni.
Specialita' Medicinale: XEROTIL
Codice pratica: N1B/06/1491
Numeri A.I.C. e Confezioni : 035113 - In tutte le confezioni.
Modifica apportata ai sensi del Regolamento (CE) 1084/2003: 7a: Sostituzione o aggiunta di un sito di produzione per imballaggio secondario per tutti i tipi di forme farmaceutiche; 7b2: Sostituzione o aggiunta di un sito di produzione per imballaggio primario di forme farmaceutiche semisolide o liquide; n.7c: Sostituzione o aggiunta di un sito di produzione per tutte le altre operazioni produttive ad eccezione del rilascio dei lotti; n.8b2: Sostituzione o aggiunta di un produttore responsabile del...
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