Authorisation For The Medicinal Product For Usoumano «Larabel».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-13&atto.codiceRedazionale=15A00940&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved January 26, 2015 V&A # 100/2015 determines the description of medicine and assigning AIC is authorised the placing on the market of the medicinal product: LARABEL, shapes and packaging: «0, 03mg/2 mg film-coated tablets» Onex (21 + 7) tablets in AL/PVC/PVDC, «0, 03mg/2 mg film-coated tablets» 3 x (21 + 7) tablets in AL/PVC/PVDC, «0, 03mg/2 mg film-coated tablets» 6 x (21 + 7) tablets in AL/PVC/PVDC under the conditions and with the specifications mentioned below: Mah: Gedeon Richter Plc., Gyömröi Ut 19-21, 1103, Budapest, Hungary.
Package: «0.03 mg/2 mg film-coated tablets» Onex (21 + 7) tablets in AL/PVC/PVDC;
A.I.C. # 043201019 (10) 196DHV (based on 32).
Package: «0, 03mg/2 mg film-coated tablets» 3 x (21 + 7) tablets in AL/PVC/PVDC;
A.I.C. # 043201021 (10) 196DHX (based on 32).
Package: «0, 03mg/2 mg film-coated tablets» 6 x (21 + 7) tablets in AL/PVC/PVDC;
A.I.C. # 043201033 (10) 196DJ9 (based on 32).
Dosage form: tablets.
Complete appliance validity: 3 years from date of manufacture.
Special precautions for storage: do not store above 30° c.
Composition: each film-coated tablet contains: active ingredient: 0.030 mg ethinyl estradiol and chlormadinone acetate 2 mg;
Ingredients: active tablets film coated tablet core: lactose monohydrate, maize starch, povidone K30, magnesium stearate;
Coating: hypromellose (2910 type), lactose monohydrate, titanium dioxide (E171), talc, macrogol 6000, propylene glycol, red iron oxide (E172).
Placebo tablets Tablet core: lactose monohydrate, povidone, crospovidone, magnesium stearate;
Coating: hypromellose (2910 type), lactose monohydrate, talc, titanium dioxide (E171), macrogol 6000, propylene glycol.
Manufacturer of the active substance: Farmabios S.p.A., Via Pavia 1, 27027 Gropello Cairoli (PV), Italy (chlormadinone acetate);
Gedeon Richter Plc., Gyömrõi ut 19-21, 1103 Budapest, Hungary (ethinyl estradiol);
N.v. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands (ethinyl estradiol);
N. V. Organon, Versemeer 4, 5347 JN Oss, Netherlands (ethinyl estradiol).
Manufacturer of the finished product: Gedeon Richter Plc., Gyömröi Ut 19-21, 1103 Budapest, Hungary (production, control, primary and secondary packaging, batch release).
Medical indications: hormonal contraception.
The decision to prescribe LARABEL must consider the current risk factors of single women, particularly those related to venous thromboembolism (VTE) and comparing the risk of VTE associated with LARABEL and that associated with other hormonal contraceptives (COC).
Classification for the purposes of new listings ' box: 0.03 mg/2 mg film-coated tablets «» Onex (21 + 7) tablets in AL/PVC/PVDC;
A.I.C. # 043201019.
New listings ' class: 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).
Package: «0, 03mg/2 mg film-coated tablets» 3 x (21 + 7) tablets in AL/PVC/PVDC;
A.I.C. # 043201021.
New listings ' class: 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).
Package: «0, 03mg/2 mg film-coated tablets» 6 x (21 + 7) tablets in AL/PVC/PVDC;
A.I.C. # 043201033.
New listings ' class: 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).
Classification for the purposes of delivery set: «0.03 mg/2 mg film-coated tablets» Onex (21 + 7) tablets in AL/PVC/PVDC;
A.I.C. # 043201019-RR: medicinal product subject to medical prescription.
Package: «0, 03mg/2 mg film-coated tablets» 3 x (21 + 7) tablets in AL/PVC/PVDC;
A.I.C. n. 043201021 RNR: prescription medicines to be renewed from time to time.
Package: «0, 03mg/2 mg film-coated tablets» 6 x (21 + 7) tablets in AL/PVC/PVDC;
A.I.C. n. 043201033 RNR: prescription medicines to be renewed from time to time.
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) under art. 107-quater, 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.