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
Retrieved February 23, 2015 V&A # 352 IP determines the parallel importation of a medicinal product authorized AUGMENTINE 875/125 mg polvo par susp. oral 30 sobres from Spain with 59518 authorization number C.N. 698232-7 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 "powder for oral suspension» 12 sachets.
AIC code: 18XS4K 042918033 (10) (32).
Pharmaceutical 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 di Gano Roberto and Claudio, via f. Pelizzola Mirko Barbarossa, 7-26824 Cavenago d'Adda (LO).
Classification for the purposes of new listings is 875 mg + 125 mg Packaging: AUGMENTIN «powder for oral suspension» 12 sachets.
AIC code: 042918033.
New listings ' class: C (nn).
The above package is placed in "special section" of the classroom under 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: 042918033.
RR-medicinal product subject to medical prescription.
Date of determination: from the day following its publication in the official journal of the Italian Republic.
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