Retrieved February 23, 2015 V&A # 354 IP determines the parallel importation of a medicinal product authorized AUGMENTINE 875/125 mg comprimidos 30 collaps. (5 × 6) from Spain with 59515 authorization number C.N. 697876-4 with the specifications mentioned below provided they are valid and enforceable at the time of the entry into force of this determination.
Importer: Farmavox S.r.l., Via Giuseppe Parini 9-20121 Milan.
Package: Augmentin "875 mg + 125 mg film-coated tablets" AIC Code tablets 12:042918058 (10) 18XS5B (based on 32) dosage form: tablets active ingredients: each tablet contains: amoxicillin trihydrate equivalent to amoxicillin 875 mg; clavulanic acid 125 mg clavulanate corresponding to;
inactive ingredients: colloidal silicon dioxide, sodium starch glycolate, magnesium stearate, microcrystalline cellulose, hypromellose, macrogol 4000 15 cps cps 5, hypromellose, macrogol 6000, titanium dioxide (E171), Dimethicone.
Therapeutic indications Augmentin it is indicated for treatment of bacterial infections incurred by germs susceptible, such as commonly found in nasal sinuses, and ear infections: respiratory tract infections, urinary tract infections, skin and soft tissue infections including dental infections, bone and joint infection.
The outer packaging and secondary packaging are allowed at the officine CIT S.r.l., Via Primo Villa 17, 20875 Burago di Molgora (MB); S.C.F. S.n.c di Gano Roberto Pelizzola and Mirko Claudio Via f. Barbarossa, 7-26824 Cavenago d'Adda-LO.
Classification for the purposes of new listings ' box: Augmentin "875 mg + 125 mg film-coated tablets" AIC Code tablets 12:042918058. New listings ' class: C (nn).
The above package is placed in "special section" of the class referred to in art. 8, paragraph 10) (c) of the Act No 537 as amended December 24, 1993, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn), pending the submission by the holder of the AIP a possible application for different classification.
Classification for the purposes of delivery set: Augmentin "875 mg + 125 mg film-coated tablets" AIC Code tablets 12:042918058. RR-medicinal product subject to medical prescription.
Date of application of the determination on the day following its publication in the official journal of the Italian Republic.