Authorisation For The Medicinal Product For Usoumano «Lactulose Fresenius».

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Lattulosio Fresenius».

Read the untranslated law here:

Retrieved December 16, 2014 # 2626 V&A determines the description of medicine and assigning AIC is authorised the placing on the market of the medicinal product: LACTULOSE FRESENIUS, shapes and packaging: "10 g/15 ml oral solution 15 ml sachets," 10 "10 g/15 ml oral solution 15 ml sachets x 20", under the conditions and with the specifications mentioned below : Mah: Fresenius Kabi Austria GmbH, Austria 36, 8055 Graz Hafnerstraße packaging: "10 g/15 ml oral solution 10 sachets 15 ml" AIC # 043473014 (10) 19GQ3Q (based on 32) packaging: "10 g/15 ml oral solution 15 ml sachets x 20" AIC # 043473026 (10) 19GQ42 (based on 32) dosage form: oral solution validity complete appliance : 3 years from date of manufacture.
Partially used bags to be disposed of special precautions for storage: do not store above 25° c.
Composition: one sachet (15 ml) contains: active ingredient: 10 g of lactulose (in the form of lactulose solution).
Ingredients: Plum taste. The taste of plum consists of dried plum, ethyl alcohol, propylene glycol, caramel color and aroma.
Manufacturer of the active substance: Fresenius Kabi Austria Gmbh, Estermannstraße 17, 4020, Linz, Austria.
Manufacturer of the finished product: Fresenius Kabi Austria Gmbh, Estermannstraße 17, 4020, Linz, Austria (production, primary and secondary packaging, qulaita ' control and batch release).
Medical indications: symptomatic relief of constipation.
Lactulose Fresenius 10 g/15 ml oral solution is indicated in adults and children and Adolescents age between 7 and 18 years.
Classification for the purposes of new listings ' packaging: "10 g/15 ml oral solution 10 sachets 15 ml" AIC # 043473014 C a box: "10 g/15 ml oral solution 15 ml sachets x 20" AIC # 043473026 C a Classification for the purpose of delivery set: "10 g/15 ml oral solution 10 sachets 15 ml" AIC # OTC 043473014 (10) : over-the-counter non-prescription medicines packaging: "10 g/15 ml oral solution" 20 sachets 15 ml AIC # 043473026: OTC over-the-counter non-prescription medicines packaging of Printed material should be marketed with labels and package leaflets comply with the attached text to the determination, under this extract.
It approved the summary of the product characteristics attached to the assessment, referred to in this excerpt.
In accordance with art. 80 paragraphs 1 and 3 of the Legislative Decree of April 24, 2006, # 219 s and the package leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The mAh avails itself of the complementary use of foreign languages, must give prior notice to the AIFA and keep available the certified translation of German texts and/or in another foreign language. In case of non-compliance with the provisions on the labelling and package leaflet shall apply sanctions under art. 82 of the aforementioned legislative decree.
Generic drug patent protection the mAh is responsible of full respect for the rights of industrial property relative to the reference product and the patent regulations provisions in force.
The mAh of the generic drug and is also responsible for full compliance with the provisions of art. 14, paragraph 2 of Legislative Decree No 219 April 24, 2006 and s, in virtue of which are not included in the printed those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosages still covered by a patent at the time of placing on the market of generic medicine.
Periodic safety update reports PSUR-at the time of granting the authorisation, the submission of the periodic safety update reports not required for this product. However, the marketing authorisation holder shall submit periodic safety update reports for this product if the product is listed as reference dates (EURD list) referred to in article 107 c, para. 7 of Directive 2010/84/EC and published on the web portal of the European Medicines Agency.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana.