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

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-20&atto.codiceRedazionale=15A02798&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved March 30, 2015 # 351/2015 of Medicine determines: GEMCITABINE FRESENIUS.
A.I.C. Holder: Fresenius Kabi Oncology Plc. -Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF-United Kingdom.
Packaging: «38 mg/ml concentrate for solution for infusion» 1 glass vial 5.26 ml-A.I.C. # 041784048 (10), 17V4RJ (32);
«38 mg/ml concentrate for solution for infusion» 1 glass vial 26.3 ml-A.I.C. # 041784051 (10), 17V4RM (32);
«38 mg/ml concentrate for solution for infusion» 1 glass vial 52.6 ml-A.I.C. # 041784063 (10), 17V4RZ (32).
Pharmaceutical form: concentrate for solution for infusion.
Composition: each ml concentrate for solution for infusion contains: active ingredient: Gemcitabine hydrochloride equivalent to 38 mg Gemcitabine.
The quantitative composition of each presentation is shown in the table below: === === === === === === === === === === === === === === === === === === === === === === === | | | Amount of | | | | | Gemcitabine (as | Volume of | Presentation | Dosage | hydrochloride) | solution | +=================+============+======================+=============+ | 5.26 200 mg/ml | 38 mg/ml | 200 mg | 5.26 ml | +-----------------+------------+----------------------+-------------+ | 26.3 mg/1000 ml | 38 mg/ml |  1000 mg | 26.3 ml | +-----------------+------------+----------------------+-------------+ | 52.6 mg/ml 2000 | 38 mg/ml |  2000 mg | 52.6 ml | +------------------+------------+----------------------+--------------+ excipients: propylene glycol, macrogol 400, sodium hydroxide (E524) (for pH adjustment), concentrated hydrochloric acid (E507) (for pH adjustment), water for injections.
Production active ingredient: Fresenius Kabi Oncology Limited-D-35, Industrial Area, Nadia District, Kalyani, West Bengal, India-741 235;
Shilpa Medicare Limited-Deosugur Industrial Area, Raichur, Karnataka, 584 170-India.
Manufacturer responsible for batch control, batch release and secondary packaging: Fresenius Kabi Oncology Plc., Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom.
Production, packaging: Fresenius Kabi Oncology Limited-Village Kishanpura, Tehsil Nalagarh, Distt. Solan, H. P. 174101 India.
Medical indications: Gemcitabine in combination with cisplatin is indicated for the treatment of locally advanced or metastatic bladder cancer.
Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas.
Gemcitabine combined with cisplatin is indicated for the first-line treatment of patients with non-small cell lung cancer (NSCLC) locally advanced or metastatic. Gemcitabine alone can be considered in elderly or with performance status equal to 2.
Gemcitabine combined with carboplatin, is indicated for the treatment of patients with locally advanced or metastatic ovarian epithelial carcinoma, in patients with relapsed disease after a relapse free interval of at least 6 months after first-line therapy with Platinum.
Gemcitabine in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who relapsed after neoadjuvant or adjuvant chemotherapy. The previous chemotherapy must have included an anthracycline unless it is clinically contraindicated.
Classification for the purposes of new listings ' 38 mg/ml concentrate for solution for infusion» 1 glass vial 5.26 ml-A.I.C. # 041784048 (10), 17V4RJ (32); new listings ' class ' C ';
«38 mg/ml concentrate for solution for infusion» 1 glass vial 26.3 ml-A.I.C. # 041784051 (10), 17V4RM (32); new listings ' class ' C ';
«38 mg/ml concentrate for solution for infusion» 1 glass vial 52.6 ml-A.I.C. # 041784063 (10), 17V4RZ (32); new listings ' class ' C '.
Classification for the purpose of the classification for the supply of the medicinal product ' Gemcitabine Fresenius ' 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) 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 its publication in the official journal of the Italian Republic.