Retrieved determines the IP V&A December 29, 2014 # 2730 is authorized the parallel importation of the medicine 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: Medifarm S.r.l., via Tiburtina # 1166/1168-00156 Rome.
Package: Lansox "30 mg capsule" 14 capsules.
A.I.C. code: 19MHG3 043630019 (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, silica, gelatin, purified water.
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 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 is secondary to your repair shop authorized repackaging Mediwin Limited, Unit 12-13 Hammer Courtwick Lane Enterprise Centre-West Sussex Littlehampton BN17 7PA, United Kingdom.
Classification for the purposes of new listings ' box: Lansox "30 mg capsule" 14 capsules.
A.I.C. code: 043630019; 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: Lansox "30 mg capsule" 14 capsules.
A.I.C. code: 043630019; RR-medicinal product subject to medical prescription.
Date of determination: from the day following its publication in the official journal of the Italian Republic.