Parallel Imports Of Medicinal Products For Human Use "augmentin".

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-23&atto.codiceRedazionale=15A02067&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Extract determines V & A IP n. 352 of 23 February 2015 and 'authorized the parallel importation of medicinal AUGMENTINE 875/125 mg polvo para susp. Oral 30 envelopes from Spain with license number 59518 CN 698232-7 with the specifications listed below, provided they are valid and effective upon the entry into force of this determination. Importer: Farmavox Srl, Via Giuseppe Parini, 9-20121 Milan. Packaging: AUGMENTIN "875 mg + 125 mg powder for oral suspension» 12 sachets. AIC code: 042918033 (base 10) 18XS4K (in base 32). Pharmaceutical form: bags. Each sachet contains: Active Ingredients: Amoxicillin trihydrate equivalent to amoxicillin 875 mg; potassium clavulanate equivalent to clavulanic acid 125 mg; excipients: crospovidone, colloidal hydrated silica, aspartame, magnesium stearate, flavor peach-lemon-strawberry. Therapeutic indications Augmentin and 'indicated for the treatment of bacterial infections incurred by sensitive germs, which is commonly encountered in infections: ear and sinus, respiratory tract infections, urinary tract infections, infections of the skin and soft tissue infections including dental infections, infection of the bones and joints. Secondary packaging It 'authorized secondary packaging at the workshops CIT Srl, via First Villa, 17-20875 Burago di Molgora (MB); SCFSnc Giovenzana Pelizzola Mirko Roberto and Claudio, Via F. Barbarossa, 7-26824 Cavenago d'Adda (LO). Classification for the purposes of reimbursement 'Pack: AUGMENTIN "875 mg + 125 mg powder for oral suspension» 12 sachets. AIC Code: 042918033. class reimbursement ': C (n). The package described above and 'placed in' special section 'of the class of art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn), pending the submission by the holder of AIP to a possible application of different classification. Classification for the supply Package: AUGMENTIN "875 mg + 125 mg powder for oral suspension» 12 sachets. AIC Code: 042918033. RR - a medicinal product subject to medical prescription. Effective date of determination, from the day following its publication in the Official Gazette of the Italian Republic.