Authorisation For The Medicinal Product For Usoumano «Doxorubicin Agila Specialties. "

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

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Retrieved determines the 59/2015 January 29, 2015 n. Medicine: DOXORUBICIN AGILA SPECIALTIES.
MAh: Agila Specialties UK Limited-New bridge street House, 30-34 New Bridge Street, London EC4V 6BJ-United Kingdom.
Package: «2 mg/ml concentrate for solution for infusion 10 mg/1 glass vial 5 ' ml;
A.I.C. # 040482010 (10) 16MF6U (based on 32).
Package: «2 mg/ml concentrate for solution for infusion 20 mg/1 glass vial 10 ' ml;
A.I.C. # 040482022 (10) 16MF76 (based on 32).
Package: «2 mg/ml concentrate for solution for infusion» 1 vial 25 ml 50 mg/glass;
A.I.C. # 040482034 (10) 16MF7L (based on 32).
Package: «2 mg/ml concentrate for solution for intravenous infusion 200 mg/1 glass vial 100 ' ml;
A.I.C. # 040482046 (10) 16MF7Y (based on 32).
Package: «2 mg/ml concentrate for solution for infusion 10 mg 1 glass vial ";
A.I.C. # 040482059 (10) 16MF8C (based on 32).
Package: «2 mg/ml concentrate for solution for intravenous infusion 50 mg 1 glass vial ";
A.I.C. # 040482061 (10) 16MF8F (based on 32).
Pharmaceutical form: powder for concentrate for solution for infusion.
Composition: one ml of reconstituted solution contains: active ingredient: 2 mg of doxorubicin hydrochloride.
Excipients: lactose monohydrate.
Batch release: Agila Specialties PolskaSp z o o-Address: 10, DaniszewskaStr, 03-230 Warsaw-Poland.
Production, primary and secondary packaging, batch control: Onco Therapies LimitedPlot No. 284-B, Bommasandra-Jigani Link Road (BJLR), IndustrialArea, Anekal Taluk, Bangalore-560-099-India.
Batch control: ExovaLochend Industrial Estate, Newbridge, Midlothian, EH28 8PL-United Kingdom.
Production active ingredient: Sicor Societa Italiana Corticosteroids S.R.L. Estate San Alessandro-13048 Santhia '-Vercelli-Italy.
Medical indications: small cell lung cancer (SCLC) breast cancer recurrent ovarian cancer intravesical Prophylaxis of recurrence of superficial bladder cancer after transureterale resection (TUR) local or systemic Treatment of advanced bladder cancer metastasized neoadjuvant therapy and adjuvant advanced soft tissue Sarcoma osteosarcoma Ewing's Sarcoma in adult Hodgkin Lymphoma non-Hodgkin Lymphoma therapy high malice introduction and consolidation in acute Lymphocytic Leukemia acute myeloblastic leukemia advanced multiple myeloma or advanced endometrial Carcinoma recurrent Wilms Tumor (in stage II high malice variants, all stages [III-IV]) Papillary thyroid cancer/advanced follicular thyroid cancer advanced Neuroblastoma anaplastic doxorubicin is frequently used in chemotherapy regimens in combination with other cytotoxic drugs.
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 medicine DOXORUBICIN AGILA SPECIALTIES is the following: 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-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 its publication in the official journal of the Italian Republic.