Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-15&atto.codiceRedazionale=15A02712&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved March 20, 2015 V&A IP determines the # 546 is authorized the parallel importation of the medicine AGOPTON 15 mg Kapseln 98 Kaps. from Germany with 36286.01.00 authorization number, which for the reasons expressed above, must be marketed under the name LANSOX and with the specifications mentioned below provided they are valid and enforceable at the time of the entry into force of this determination: importer: PRICETAG SPA with registered office in Vasil Levski St. 103-1000 Sofia;
Package: LANSOX "15 mg capsule" AIC Code capsules 14:043713027 (10) 19Q0J3 (based on 32) dosage form: capsules, each capsule contains: active ingredient: Lansoprazole 15 mg;
Excipients: magnesium carbonate heavy, sucrose, corn starch, hydroxypropyl cellulose, methacrylic acid copolymer-ethyl acrylate (1:1), talc, macrogol 8000, titanium dioxide, polysorbate 80, sodium lauryl sulphate, colloidal silicon dioxide, gelatin, purified water.
Therapeutic indications • treatment of duodenal and gastric ulcer • treatment of reflux oesophagitis • reflux esophagitis prophylaxis • eradication of Helicobacter pylori (H. pylori) administered with appropriate antibiotic therapy for the treatment of ulcers associated with h. pylori • treatment of benign gastric ulcers and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) in patients who require continuous treatment with NSAIDs • prophylaxis of gastric and duodenal ulcers associated with use of NSAIDs in patients at risk who require a continuous therapy (see section 4.2) • symptomatic gastroesophageal reflux disease Zollinger-Ellison Syndrome secondary packaging and secondary packaging are allowed at the workshops FIEGE LOGISTICS ITALIA S.p.A., Via Amendola 1, 20090 Caleppio di Settala (MI); S.C.F. S.n. c. By Gano Roberto and Claudio F 7-26824 Pelizzola Mirko Barbarossa, CAVENAGO d'Adda-LO; FALORNI s.r.l. Via Provinciale Lucchese 51-loc. Masotti 51030 Serravalle Pistoiese (PT); PriceTag EAD, Business Center Serdika, 2E Ivan Geshov Blvd.-1000 Sofia;
Classification for the purposes of new listings ' box: LANSOX "15 mg capsule" AIC Code capsules 14:043713027; New listings ' class: C (nn) the package described above is placed in "special section" of the class referred to in 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: LANSOX "15 mg capsule" AIC Code capsules 14:043713027; RR-prescription medicines;
Date of determination: from the day following its publication in the official journal of the Italian Republic.
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