Retrieved February 20, 2015 V&A # 325 IP determines the parallel importation of a medicinal product authorized «Agopton» 30 mg Kapseln 98 Kaps. from Germany with 36286.00.00 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 at Vasil Levski St. 103-1000 Sofia.
Package: «Lansox» «30 mg capsule» 14 capsules.
A.I.C. code: 19Q0HR 043713015 (10) (32).
Dosage form: capsules.
Each capsule contains: active ingredient: lansoprazole 30 mg;
excipients: magnesium carbonate heavy, sucrose, corn starch, hydroxypropyl cellulose, methacrylic acid copolymer-ethyl acrylate (1:1), macrogol 8000, talc, titanium dioxide (E171), polysorbate 80, sodium dodecyl sulfate, colloidal silica, gelatin.
Indications treatment of duodenal and gastric ulcer.
Treatment of reflux esophagitis.
Reflux esophagitis prophylaxis.
Eradication of Helicobacter pylori (H. pylori) administered with appropriate antibiotic therapy for the treatment of ulcers associated with Helicobacter 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.
The outer packaging and secondary packaging are allowed at le officine Fiege Logistics Italy S.p.A., via Amendola # 1-20090 Caleppio di Settala (Milano); S.C.F. S.n.c. By Gano Roberto and Claudio, via f. Pelizzola Mirko Barbarossa # 7-26824 Cavenago d'Adda (Lodi); Falorni s.r.l., via Provinciale Lucchese # 51-loc. Masotti 51030 Serravalle Pistoiese (Pistoia); PriceTag EAD, Business Center Serdika, 2E Ivan Geshov Blvd.-1000 Sofia.
Classification for the purposes of new listings ' box: «Lansox» «30 mg capsule» 14 capsules.
A.I.C. code: 043713015; 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: «Lansox» «30 mg capsule» 14 capsules.
A.I.C. code: 043713015; RR-prescription medicines.
Date of determination: from the day following its publication in the official journal of the Italian Republic.