Authorisation For The Medicinal Product For Usoumano «Novalgidol».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-09&atto.codiceRedazionale=14A10117&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved determines the 2677/2014 December 16, 2014 n V & Description and attribution A.I.C. number: is authorized the placing on the market of the medicinal product: NOVALGIDOL, in the forms and package sizes: 200 mg capsules, soft capsules «12» in PVC/PVDC/AL; «200 mg capsules, soft» 24 capsules in blister PVC/PVDC/AL; «400 mg capsules, soft capsules in 10 ' PVC/PVDC/AL; «400 mg capsules, soft» 12 capsules in blister PVC/PVDC/AL; «400 mg 20 capsules, soft capsules» in PVC/PVDC/AL, under the conditions and with the specifications below.
A.I.C. holder: Sanofi-Aventis S.p.a., with registered office and tax domicile in Milan, viale Luigi Bodio # 37/B, postal code 20158, Italy, tax code # 00832400154.
Packaging: 200 mg capsules, soft capsules «12» in PVC/PVDC/AL, A.I.C. # 043554017 (10), 19K571 (32);
«200 mg capsules, soft» 24 capsules in blister PVC/PVDC/AL, A.I.C. # 043554029 (10), 19K57F (32).
Pharmaceutical form: soft capsules.
Complete appliance validity: one year from the date of manufacture.
Manufacturer of the active substance: Albemarle Corporation plant in 725 Cannon Bridge Road, Orangeburg, South Carolina 29-115-United States of America; Hubei Biocause Pharmaceutical Granules co. Ltd., plant in 122 Yangwan Jingmen City, Hubei Province, China Road 448000-China.
Manufacturer of the finished product: Saneca Pharmaceutical A.S., plant site in Nitrianska ' 100, Hlohovec, 920 27 Slovakia (production, primary and secondary packaging, control and release); Sanofi Aventis S.p.a., factory site in Highway 17, km 22-67019 Scoppito-L'aquila (production, primary and secondary packaging, control and release).
Composition: each soft capsule contains: active ingredient: ibuprofen 200 mg;
excipients: macrogol 600; potassium hydroxide 85% (E525); jelly; sorbitol liquid, partially dehydrated (E420); carmine red 43% (E120); purified water.
Packaging: 400 mg capsules, soft capsules «10» in PVC/PVDC/AL, A.I.C. # 043554031 (10), 19K57H (32);
«400 mg capsules, soft» 12 capsules in blister PVC/PVDC/AL, A.I.C. # 043554043 (10), 19K57V (32);
«400 mg 20 capsules, soft capsules» in PVC/PVDC/AL, A.I.C. # 043554056 (10), 19K588 (32).
Pharmaceutical form: soft capsules.
Complete appliance validity: one year from the date of manufacture.
Manufacturer of the active substance: Albemarle Corporation, factory site in 725 Cannon Bridge Road, Orangeburg, South Carolina 29 -115-United States of America; Hubei Biocause Pharmaceutical Granules co. Ltd., plant in 122 Yangwan Jingmen City, Hubei Province, China Road 448000-China.
Manufacturer of the finished product: Saneca Pharmaceutical A.S., plant site in Nitrianska ' 100, Hlohovec, 920 27 Slovakia (production, primary and secondary packaging, control and release); Sanofi Aventis S.p.a., factory site in Highway 17, km 22-67019 Scoppito-L'aquila (production, primary and secondary packaging, control and release).
Composition: each soft capsule contains: active ingredient: ibuprofen 400 mg;
excipients: macrogol 600; potassium hydroxide 85% (E525); jelly; sorbitol liquid, partially dehydrated (E420); carmine red 43% (E120); purified water.
Medical indications: «Novalgidol» 200 mg is indicated for the symptomatic treatment of headache, headache, dental pain, back pain, dysmenorrhea, muscle pain, neuralgia, rheumatic pain, not serious arthritic conditions, colds accompanied by fever and flu.
«Novalgidol» 400 mg is recommended for adults and adolescents 12 years of age greater than (or equal to 40 kg body weight).
Given the amount of active ingredient contained in a capsule, «Novalgidol» 200 mg is recommended for adults and children over 6 years of age (body weight at or above 20 kg).
Classification for the purposes of new listings ' packaging: A.I.C. # 043554017-200 mg capsules, soft capsules «12» in PVC/PVDC/AL, new listings class is: "C-bis ';
A.I.C. # 043554029-' 200 mg capsules, soft» 24 capsules in blister PVC/PVDC/AL, new listings class is: "C-bis ';
A.I.C. # 043554031-400 mg capsules, soft capsules «10» in PVC/PVDC/AL, new listings class is: "C-bis ';
A.I.C. # 043554043-400 mg capsules, soft capsules «12» in PVC/PVDC/AL, new listings class is: "C-bis ';
A.I.C. # 043554056-400 mg capsules, soft capsules» «20 in PVC/PVDC/AL, new listings class is: "C-bis '.
Classification for the purpose of packaging: A.I.C. # 043554017-200 mg capsules, soft capsules «12» in PVC/PVDC/AL-OTC: medicinal product not subject to medical prescription;
A.I.C. # 043554029-' 200 mg capsules, soft» 24 capsules in blister PVC/PVDC/AL-OTC: medicinal product not subject to medical prescription;
A.I.C. # 043554031-400 mg capsules, soft capsules «10» in PVC/PVDC/AL-OTC: medicinal product not subject to medical prescription;
A.I.C. # 043554043-400 mg capsules, soft capsules «12» in PVC/PVDC/AL-OTC: medicinal product not subject to medical prescription;
A.I.C. # 043554056-400 mg capsules, soft capsules» «20 in PVC/PVDC/AL-OTC: medicinal product not subject to medical prescription over the counter.
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 Legislative Decree No 219, April 24, 2006 and subsequent amendments and supplements the leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The holder of the A.I.C. 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.
Patent protection

The holder of the A.I.C. the generic drug is exclusively responsible for the full respect for the rights of industrial property relative to the reference product and the patent regulations provisions in force.
The holder of the A.I.C. generic drugs and is also responsible for full compliance with the provisions of art. April 24, 2006, 14 paragraph 2 of Legislative Decree No. 219, and subsequent amendments and supplements, 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) under art. 107 c, paragraph 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 in the official journal of the Italian Republic.