Parallel Imports Of The Medicinal Product For Human Use «Zirtec»

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-30&atto.codiceRedazionale=15A00504&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved December 29, 2014 V&A # 2722 IP determines the parallel import of a medicinal product is authorised for ZYRTEC 10 mg pastiglie dimagranti powlekane (film coated tablets) 20 tabl. from Poland with return authorization number R/1846, with the specifications below and provided that they are valid and effective on the date of entry into force of this determination.
Importer: Gekofar S.r.l. with registered office in piazza Duomo # 16-20122 Milano.
Package: Zirtec "10 mg film-coated tablets" 20 tablets.
A.I.C. code: 19MGGT 043629017 (10) (32).
Dosage form: tablets.
Each coated tablet contains: active ingredient: cetirizine dihydrochloride 10 mg;
Other ingredients: Tablet core: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. Film coating: Opadry Y-1-7000 (hypromellose, titanium dioxide (E 171), macrogol 400).
Therapeutic indications adults and children from 6 years of age: Cetirizine is indicated for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
Cetirizine is indicated for the symptomatic treatment of chronic idiopathic urticaria.
The outer packaging and secondary packaging are allowed at le officine Fiege Logistics Italy S.p.A., via Amendola # 1-20090 Caleppio di Settala (MI); S.C.F. S.n.c. By Gano Roberto and Claudio, via f. Pelizzola Mirko Barbarossa # 7-26824 Cavenago d'Adda (LO); CIT S.r.l., via Primo Villa # 17-20875 Burago Molgora (MB).
Classification for the purposes of new listings ' box: Zirtec "10 mg film-coated tablets" 20 tablets.
A.I.C. code: 043629017; 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 law 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: Zirtec "10 mg film-coated tablets" 20 tablets.
A.I.C. code: 043629017; RR-medicinal product subject to medical prescription.
Date of determination: from the day following its publication in the official journal of the Italian Republic.