| Medicine Name (İlaç Adı): | Simponi | Therapeutic Area (Terapötik Bölge): | Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Arthritis, Rheumatoid |
| Active Substance (Aktif Madde): | Golimumab | Product Number (Ürün Numarası): | EMEA/H/C/000992 |
| ATC Code (ATC Kodu): | L04AB06 | Authorisation Status (Yetkilendirme Durumu): | Authorised |
| International Non-Proprietary Name (INN) / Ortak İsim: | golimumab | Additional Monitoring (Ek İzleme): | no |
| Generic (Jenerik): | no | Biosimilar (Biyobenzer): | no |
| Conditional Approval (Şartlı Onay): | no | Exceptional Circumstances (İstisnai Durumlar): | no |
| Accelerated Assessment (Hızlandırılmış Değerlendirme): | no | Orphan Medicine (Nadir Hastalık İlacı): | no |
| Marketing Authorisation Date (Pazarlama Yetkilendirme Tarihi): | 1.10.2009 | Marketing Authorisation Holder/Company Name (Şirket Adı): | Janssen Biologics B.V. |
| Human Pharmacotherapeutic Group (İnsan Farmakoterapötik Grubu): | Immunosuppressants | Decision Date (Görüş Tarihi): | 11.10.2019 |
| Condition / İndication (Şart / Edikasyon): | Rheumatoid arthritis (RA), , Simponi, in combination with methotrexate (MTX), is indicated for:, , the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX has been inadequate., the treatment of severe, active and progressive rheumatoid arthritis 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 ray and to improve physical function., For information regarding the polyarticular juvenile idiopathic arthritis indication, please see the Simponi 50 mg SmPC.Psoriatic arthritis (PsA), , Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.Axial spondyloarthritis, , Ankylosing spondylitis (AS), , Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.Non radiographic axial spondyloarthritis (nr Axial SpA), , Simponi is indicated for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).Ulcerative colitis (UC), , Simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies., , Juvenile idiopathic arthritis, , Polyarticular juvenile idiopathic arthritis (pJIA), , Simponi in combination with methotrexate (MTX) is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX., , Rheumatoid arthritis (RA), , Simponi, in combination with methotrexate (MTX), is indicated for:, , the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX has been inadequate., the treatment of severe, active and progressive rheumatoid arthritis 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 ray and to improve physical function.Juvenile idiopathic arthritis, , Polyarticular juvenile idiopathic arthritis (pJIA), , Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.Psoriatic arthritis (PsA), , Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.Axial spondyloarthritis, , Ankylosing spondylitis (AS), , Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.Non radiographic axial spondyloarthritis (nr Axial SpA), , Simponi is indicated for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).Ulcerative colitis (UC), , Simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies., | First Published (İlk Yayın Tarihi): | 2.07.2018 |
| Revision Date (Revizyon Tarihi): | 37 | Revision Date (Revizyon Tarihi): | 17.10.2019 |
| EPAR (Avrupa Kamu Değerlendirme Raporları): |
Avrupa Birliği - Avrupa İlaç Ajansı (European Medicines Agency) tarafından hazırlanan Avrupa Birliği düzeyinde izin verilen ilaçların bilgilerine yer verilmektedir. EPAR (Avrupa Kamu Değerlendirme Raporları) kısmında yer alan linkten, Avrupa Birliği düzeyinde izin verilen ilaçların tam bilimsel değerlendirme raporlarına, ilaç içerikleri, ilaçların ne için kullanıldıkları, nasıl kullanıldıkları, ilacın nasıl çalıştığı, ilacın nasıl araştırıldığı, çalışmalar sırasında ilacın ne faydası olduğu, ilacın riskleri, ilacın neden onaylandığı, ilaç hakkında diğer genel bilgilere yer verilmektedir. Ayrıca ilacın yetkilendirme bilgileri, ürün bilgisi ve değerlendirme geçmişi bilgileri de yer almaktadır. EPAR'lar ayrıca soru-cevap biçiminde ve paket broşüründe halka açık bir genel bakış içerir. Pazarlama iznini reddetmiş veya onaylandıktan sonra askıya alınmış veya geri çekilmiş ilaçlar hakkında bilgi de bulabilirsiniz.
