COMUNICATO - Autorizzazione all''immissione in commercio del medicinale «Ibupas» (11A13104)
Estratto determinazione V & A.N n. 1130 del 16 settembre 2011
Descrizione del medicinale e attribuzione n. AIC: e' autorizzata l'immissione in commercio del medicinale: «IBUPAS», anche nella forma e confezione: «136 mg cerotto medicato» 7 cerotti con le specificazioni di seguito indicate, a condizione che siano efficaci alla data di entrata in vigore della presente determinazione.
Titolare AIC: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A con sede legale e domicilio fiscale in 00144 - Roma, viale Shakespeare, 47, codice fiscale 00410650584.
Confezione: «136 mg cerotto medicato» 7 cerotti - AIC n. 036439026 (in base 10) 12S0ZL (in base 32).
Forma farmaceutica: cerotto medicato.
Validita' prodotto integro: 2 anni dalla data di fabbricazione.
Produttore del principio attivo: Albemarle Corporation 725 Cannon Bridge Road USA - 29115 Orangburg, South Carolina e Dr Reddy's Laboratories LTD Plot n. 9/A Phase III Ida Jeedimetla - IND - 500 055 Hyderabad, Andhra Pradesh (India).
Produttore del prodotto finito: LTS Lohmann Therapie - Systeme AG Lohmanstrasse, 2 Andernach (Germania) D-56626 (produzione e confezionamento primario); Enestia Klöcknerstraat 1, Hamont - Achel, Limburg, B - 3930 Belgio (confezionamento primario e confezionamento secondario) e Sigma-Tau Industrie Farmaceutiche Riunite S.p.A con sede legale e domicilio fiscale in Pomezia (Roma), via Pontina Km 30,400 (confezionamento secondario e rilascio dei lotti).
Composizione: un cerotto medicato contiene:
principio attivo: Ibuprofene 136 mg;
eccipienti: Sale di...
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