Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-30&atto.codiceRedazionale=15A00536&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved determines the IP V&A December 30, 2014 # 2745 authorized BETASERC 16 mg tablet parallel imports of the medicinal product PVC/PVDC/Alu 60 tabs from Hungary with return authorization number OGYI-T-10004/05, which should be placed on the market with the specifications mentioned below provided they are valid and enforceable at the time of the entry into force of this determination.
Importer: GMM FARMA S.r.l. CIS di Nola 8105/10-80035 Nola Lots 8, Island.
Package: Betaserc 16 mg tablets "» 20 tablets.
A.I.C. code: 19MR80 043638016 (10) (32).
Dosage form: tablets.
Composition: each tablet contains: active ingredients: betahistine dihydrochloride 16 mg;
excipients: microcrystalline cellulose, mannitol, citric acid, colloidal silicon dioxide, talc.
Medical indications: Betaserc is indicated in Meniere's syndrome.
Secondary secondary authorised repackaging repackaging at officine Pharma Partners S.r.l. Via Locchi 112-50141 Florence; De Health S.r.l. Via Antonio Biasini, 26-26015 Soresina (CR); FIEGE Logistics Italy S.p.A., Via Amendola 1, 20090 Caleppio di Settala (MI); S.C.F. S.n.c di Gano Roberto Pelizzola and Mirko Claudio Via f. Barbarossa, 7-26824 Cavenago d'Adda;
Classification for the purposes of new listings is Betaserc 16 mg tablets 20 ' container: ' tablets.
A.I.C. code: 043638016; 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: Betaserc 16 mg tablets "» 20 tablets.
A.I.C. code: 043638016; RR-prescription medicines. Date of determination: from the day following its publication in the official journal of the Italian Republic.
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