Parallel Imports Of The Medicinal Product For Human Use "augmentin".

Original Language Title: Importazione parallela del medicinale per uso umano «Augmentin».

Read the untranslated law here:

Retrieved February 23, 2015 V&A # 351 IP determines the parallel importation of a medicinal product authorized AUGMENTINE 875/125 mg polvo par susp. oral 30 sobres from Spain with license number 698231-0 with C.N. 59518 specifications below if 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 powder for oral suspension" 12 sachets AIC Code: 042918045 (10) 18XS4K (based on 32) dosage form: sachets each sachet contains: active ingredients: amoxicillin trihydrate equivalent to amoxicillin 875 mg; clavulanic acid 125 mg clavulanate corresponding to;
other ingredients: crospovidone, colloidal hydrated silica, aspartame, magnesium stearate, peach-lemon-Strawberry aroma.
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. of 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 powder for oral suspension" 12 sachets AIC Code: 042918045. New listings ' class: C (nn) the package described above 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 powder for oral suspension" 12 sachets AIC Code: 042918045. 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.