Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-30&atto.codiceRedazionale=15A00508&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved December 29, 2014 V&A # 2719 IP determines the parallel importation of a medicinal product authorized STILNOX compressed filmed 10 tabl. films from Romania with permission number 1344/2009/01 with the specifications mentioned below provided they are valid and enforceable at the time of the entry into force of this determination.
Importer: Gekofar S.r.l., piazza Duomo # 16-20122 Milano.
Package: Stilnox "10 mg film-coated tablets" 30 tablets.
A.I.C. code: 17BX66 041252038 (10) (32).
Dosage form: tablets.
Composition: each film-coated tablet contains: active ingredient: zolpidem tartrate 10 mg;
Excipients: lactose monohydrate; microcrystalline cellulose; hypromellose; sodium starch glycolate, magnesium stearate;
Coating: hypromellose; titanium dioxide; MACROGOL 400.
Therapeutic indications short term treatment of insomnia.
Benzodiazepines or benzodiazepiniche-like substances are indicated only in cases of severe insomnia, debilitating or likely to cause deep malaise.
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: Stilnox "10 mg film-coated tablets" 30 tablets-A.I.C. Code # 041252038; 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: Stilnox "10 mg film-coated tablets" 30 tablets-A.I.C. Code # 041252038; RR-prescription medicines.
Date of determination: from the day following its publication in the official journal of the Italian Republic.
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