For new listings and sales price of the medicinal product SIMPONI (golimumab)-authorized centrally by the European Commission with the European decision of September 19, 2013 and included in the Community register of medicinal products with numbers: 1/09/546/EU/005 100 mg solution for injection in pre-filled pen (glass) 1 ml-subcutaneous-1 prefilled pen;
EU/1/09/546/007 100 mg injection solution in prefilled syringe 1 ml (glass)-subcutaneous-1 prefilled syringe.
A.I.C. Holder: Janssen Biologics B.V.
The DIRECTOR-GENERAL having regard to articles 8 and 9 of legislative decree July 30, 1999, # 300; Visto l'art. September 30, 2003 48 of Decree-Law n. 269, converted into law November 24, 2003, n. 326, establishing the Italian medicines agency; Having regard to the Decree of the Minister of health in consultation with the Ministers for public administration and Economics and finance dated September 20, 2004, n. 245 laying down the rules of organisation and operation of the Italian Medicines Agency, pursuant to paragraph 13 of article. the aforementioned 48 as amended by order No. 53 of the Minister of health, in consultation with the Ministers for public administration and simplification and of economy and Finance of the March 29, 2012; Having regard to the Legislative Decree March 30, 2001, n. 165; Having regard to act July 15, 2002, # 145; Having regard to the Decree of the Minister of health of November 8, 2011, recorded by the Central Office of the budget to the register «Simple» Visas, sheet # 1282, dated November 14, 2011, with which he was appointed Director General of the Italian Medicines Agency. Luca Pani, as from November 16, 2011; Having regard to act December 24, 1993, no. 537 concerning "public finance" corrective action with particular reference to art. 8; Visto l'art. 85, paragraph 20 of the law December 23, 2000, n. 388; Visto l'art. 1, paragraph 40, December 23, 1996, law n. 662 laying «rationalization measures of public finance ", which identifies the margins of distribution for pharmaceutical companies, wholesalers and pharmacists; Having regard to the December 14, 2000, law # 376 laying "discipline of health sports and activities in the fight against doping '; Visto l'art. 48, paragraph 33, November 24, 2003, law No. 326, which has negotiating the price for products reimbursed by authorisation holders between agency and S. N.; Having regard to the Legislative Decree of April 24, 2006, n. 219, published in the Gazzetta Ufficiale della Repubblica italiana n. 142 of June 21, 2006 on the introduction of Directive 2001/83/EC (and subsequent amending directives) on the Community code relating to medicinal products for human use and Directive 2003/94/EC; Having regard to the 1 February 2001 CIPE; Having regard to Council Regulation No 726/2004/EC; View the "notes October 29, 2004 determination AIFA 2004 (Revision Notes CUF) ', published in the ordinary supplement to the official journal # 259 of November 4, 2004 as amended; View AIFA'S determination of July 3, 2006 published in the official journal-General series-# 156 of July 7, 2006; View AIFA determination of September 27, 2006 published in the official journal-General series-# 227, September 29, 2006 concerning "maneuver to the Government subsidized and non-subsidized pharmaceutical shopping»; Having regard to the application with which the firm Janssen Biologics B.V. has applied for classification, for the purposes of new listings '; Having regard to the opinion of the scientific and Technical Advisory Committee at its meeting of July 21, 2014; Having regard to the opinion of the pricing and reimbursement at its meeting of September 29, 2014; Having regard to resolution No. 40 on November 6, 2014 AIFA's Board of Directors adopted on the proposal of the Director General; Whereas for the proper management of the various stages of deployment, the medicinal product should be assigned a national identification number;
Causes: Art. 1 Description and attribution MA To SIMPONI (golimumab) medicinal product packaging indicated are given the following national identification numbers: box: 100 mg solution for injection in pre-filled pen (glass) 1 ml-subcutaneous-1 prefilled pen;
A.I.C. # 039541053/E (10) 15QQ9X (based on 32).
Packaging: 100 mg injection solution in prefilled syringe 1 ml (glass)-subcutaneous-1 prefilled syringe;
A.I.C. # 039541077/E (10) 15QQBP (based on 32). Medical indications: rheumatoid arthritis (RA): «Simponi», in combination with methotrexate (MTX), is indicated for the treatment of rheumatoid arthritis in active stage of moderate to severe, in adult patients, when responding to anti-rheumatic drugs that modify (DMARDs Disease-Modifying Anti-Rheumatic Drug), including MTX, was inadequate;
the treatment of severe rheumatoid arthritis, active and progressive in adults not previously treated with MTX. «Simponi», in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by x-rays and improve physical function.
Psoriatic arthritis (AP): «Simponi», individually or in combination with methotrexate (MTX), is indicated for the treatment of active and progressive psoriatic arthritis in adults, where it has been inadequate response to previous treatments DMARDs. «Simponi» has been shown to reduce the rate of progression of peripheral joint damage as measured by x-rays in patients with polyarticular symmetrical disease subtypes and to improve physical function.
Ankylosing spondylitis (as): «Simponi» is indicated for the treatment of severe, active ankylosing spondylitis in adults who have not responded adequately to conventional therapies.
Ulcerative colitis (CU): «Simponi is indicated for the treatment of ulcerative colitis in active phase of moderate to severe, in adult patients who have not responded adequately to conventional therapy, including corticosteroids and 6-Mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant or where there is a medical contraindication to these therapies.