Teva Italia S.r.l.
Modifiche secondarie di un'autorizzazione all'immissione in commercio di specialita' medicinali per uso umano. Modifiche apportate ai sensi del decreto legislativo 29 dicembre 2007 n. 274.
Modifiche apportate ai sensi del Regolamento 1084/2003/CE:
Medicinale: Amoxicillina/Acido clavulanico Teva Codice A.I.C.:
036966/M - in tutte le confezioni autorizzate.
Modifiche apportate ai sensi del Regolamento 1084/2003/CE:
1) Tipo IA n. 15.a: Presentazione di un certificato d'idoneita' della farmacopea europea aggiornato relativo ad un principio attivo da parte di un produttore attualmente approvato - Sandoz Industrial Products SA, da 'R1-CEP 1999-036-Rev 01' a 'R1-CEP 1999-036-Rev 03' (NL/H/0371/001-002/IA/003).
2) Tipo IA n. 12.a: restringimento dei limiti di una specifica del principio attivo in accordo ai requisiti del R1-CEP 1999-036-Rev 03: solventi residui, da 'Metile acetato NMT 0,6%' a 'Metile acetato NMT 5000 ppm'' (NL/H/0371/001-002/IA/004).
3) Tipo IA n. 15.a: Presentazione di un certificato d'idoneita' della farmacopea europea aggiornato relativo ad un principio attivo da parte di un produttore attualmente approvato - Sandoz Industrial Products SA, da 'R1-CEP 1998-142-Rev 00' a R1-CEP 1998-142-Rev 01 (NL/H/0371/001-002/IA/005).
4) Tipo IA n. 12.a: restringimento dei limiti di una specifica del principio attivo in accordo ai requisiti del R1-CEP 1998-142-Rev.01: sostanze correlate, aggiunta di 'Qualsiasi altra impurezza: NMT 0,2%' (NL/H/0371/001-002/IA/006).
Medicinale: Cefonicid Teva Codice A.I.C.:
033051 - in tutte le confezioni autorizzate.
Modifiche apportate ai sensi del Regolamento 1084/2003/CE:
Tipo IA n. 6.a: Modifica del codice atc - prodotto medicinale per uso umano (da J01DA17 a J01DC06).
Medicinale: Lamotrigina Teva Codice A.I.C.:
037721/M - in tutte le confezioni autorizzate.
1) Tipo IA n. 37.a: Aggiornamento dei riferimenti delle specifiche del prodotto finito, da Farmacopea Britannica a Farmacopea Europea per saggio di dissoluzione, di disintegrazione e per la finezza della dispersione (codice procedura MRP UK/H/0836/001-006/IA/006).
2) Tipo IA n. 7.b.1 + 7.a: Aggiunta del sito Teva Pharmaceutical Industries Limited, 2...
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