Authorisation For The Medicinal Product For Usoumano «Irinotecan Csc».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-09&atto.codiceRedazionale=15A00032&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved determines 1552/2014 of medicinal product # December 18, 2014: IRINOTECAN CSC.
A.I.C. holder: CSC Pharmaceuticals Handels GmbH Gewerbestrasse nn. 2102 Bisamberg, Austria 18-20.
Packaging: «20 mg/ml concentrate for solution for infusion» 1 glass vial 2 ml-A.I.C. # 040933018 (10) 1715NU (based on 32);
«20 mg/ml concentrate for solution for infusion» 1 glass vial 5 ml-A.I.C. # 040933020 (10) 1715NW (based on 32);
«20 mg/ml concentrate for solution for infusion» 1 glass vial 15 ml-A.I.C. # 040933032 (10) 1715P8 (based on 32);
«20 mg/ml concentrate for solution for infusion» 1 glass vial 25 ml-A.I.C. # 040933044 (10) 1715PN (based on 32).
Pharmaceutical form: concentrate for solution for infusion.
Composition: each ml of concentrate contains: active ingredient: 20 mg of irinotecan hydrochloride trihydrate equivalent to 17.33 mg/ml of irinotecan;
vial with 2 ml (40 mg irinotecan hydrochloride trihydrate);
5 ml vial (100 mg irinotecan hydrochloride trihydrate);
15 ml vial (300 mg irinotecan hydrochloride trihydrate);
vial of 25 ml (500 mg irinotecan hydrochloride trihydrate).
Other ingredients: sorbitol, E420;
Lactic acid;
Sodium hydroxide (for pH adjustment), hydrochloric acid (to adjust pH);
Water for injections.
Production active ingredient: Fermion Oy Oulu Plant, Lääketehtaantie 2, FIN-90650 OULU Finland.
Production: GP Pharm, s. A_Pol. IND. Els Vinyets-Els Fogars Sector 2, Carretera comarcal C244, Km 22, 08777 Sant Quinti de Mediona Spain.
Primary and secondary packaging: GP Pharm, s. A_Pol. IND. Els Vinyets-Els Fogars Sector 2, Carretera comarcal C244, Km 22, 08777 Sant Quinti de Mediona Spain.
Quality control: GP Pharm, s. A_Pol. IND. Els Vinyets-Els Fogars Sector 2, Carretera comarcal C244, Km 22, 08777 Sant Quinti de Mediona Spain.
SABATER Argemi, 08950 Esplugues de Llobregat 13.15 Pharma SA_Josep, Barcelona Spain.
Batch release: GP Pharm, s. A_PoI. IND. Els Vinyets-Els Fogars Sector 2, Carretera comarcal C244, Km 22, 08777 Sant Quinti de Mediona Spain.
Medical indications: Irinotecan is indicated for the treatment of patients with advanced colorectal cancer: in association with 5-fluorouracil (5-FU) and folinic acid in patients without prior chemotherapy for advanced disease, as monotherapy in patients who did not respond to therapeutic scheme with 5-fluorouracil.
Irinotecan in combination with cetuximab is indicated for the treatment of patients with metastatic cancer of the colon and rectum that express epidermal growth factor receptor (EGFR), KRAS wild-type, who had not received prior treatment for metastatic disease or after failure of cytotoxic therapy which includes irinotecan.
Irinotecan in combination with 5-fluorouracil (5-FU), folinic acid and bevacizumab is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum.
Irinotecan in combination with Capecitabine, with or without bevacizumab, is indicated for first-line treatment of patients with metastatic colorectal cancer.
Classification for the purposes of new listings is the packs referred to in art. 1 are placed, by virtue of art. 12, paragraph 5, of Decree-Law No September 13, 2012. 158, converted, with amendments, by law November 8, 2012, n. 189, in the section dedicated to drugs not yet evaluated for the purposes of new listings, the class of article. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, called class C (nn).
Classification for the purpose of the classification for the purposes of the supply of the drug IRINOTECAN CSC is as follows: medicinal product subject to medical prescription, to be used only in hospitals or in similar structure to it (OSP).
Printed packaging of the medicinal product should be marketed with labels and package leaflets comply with the text annexed to this determination.
It approved the summary of the product characteristics attached to this determination.
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-quater, para. 7 of Directive 2010/84/EC and published on the web portal of the European Medicines Agency.
Final provisions this determination takes effect on the day following its publication in the official journal of the Italian Republic, and will be notified to the company marketing authorisation holder.