Prodotti FORMENTI - S.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio di medicinale per uso umano. (Comunicazione Agenzia italiana del farmaco - Ufficio pratiche comunitarie del 7 luglio 2006). Presa d'atto UPC/I/4616/2006.
Titolare: Prodotti Formenti S.r.l.
Specialita' medicinale: CONTRAMAL.
Confezioni e numeri di A.I.C.:
'SR 150' 10 compresse rilascio prolungato 150 mg - A.I.C. n. 028853075/M;
'SR 200' 10 compresse rilascio prolungato 200 mg - A.I.C. n. 028853087/M.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: Variazione tipo IB, n. 17.a: Modifica del periodo di ripetizione della prova del principio attivo prodotto dal sito Gr¸nenthal GmbH (Gerrnania) - DE/H/0108/001-003/IB/013.
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