Retrieved December 30, 2014 V&A # 2742 IP determines the parallel importation of a medicinal product authorized BETASERC 24 mg tablets 50 tabs PVC/PVDC/Alu from Hungary with OGYI-authorization number T-10004/01, 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.
Packaging: 20 tablets 24 mg tablets Betaserc «».
A.I.C. code: 19MR8D 043638028 (10) (32).
Dosage form: tablets.
Composition: each tablet contains: active ingredients: betahistine dihydrochloride 24 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. of Gano Roberto Pelizzola and Mirko Claudio Via f. Barbarossa, 7-26824 Cavenago d'Adda;
Classification for the purposes of new listings ' box: 20 tablets 24 mg tablets Betaserc «».
A.I.C. code: 043638028; 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 «24 mg tablets» 20 tablets.
A.I.C. code: 043638028; RR-prescription medicines.
Date of determination: from the day following its publication in the official journal of the Italian Republic.