| Medicine Name (İlaç Adı): | Benepali | Therapeutic Area (Terapötik Bölge): | Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis |
| Active Substance (Aktif Madde): | etanercept | Product Number (Ürün Numarası): | EMEA/H/C/004007 |
| ATC Code (ATC Kodu): | L04AB01 | Authorisation Status (Yetkilendirme Durumu): | Authorised |
| International Non-Proprietary Name (INN) / Ortak İsim: | etanercept | Additional Monitoring (Ek İzleme): | yes |
| Generic (Jenerik): | no | Biosimilar (Biyobenzer): | yes |
| 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): | 13.01.2016 | Marketing Authorisation Holder/Company Name (Şirket Adı): | Samsung Bioepis NL B.V. |
| Human Pharmacotherapeutic Group (İnsan Farmakoterapötik Grubu): | Immunosuppressants | Decision Date (Görüş Tarihi): | 18.12.2019 |
| Condition / İndication (Şart / Edikasyon): | Rheumatoid arthritis, , Benepali in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate., , Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate., , Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate., , Benepali, alone or in combination with methotrexate, 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, , Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate., , Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate., , Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy., , Etanercept has not been studied in children aged less than 2 years., , Psoriatic arthritis, , Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease., , Axial spondyloarthritis, , Ankylosing spondylitis, , Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy., , Non-radiographic axial spondyloarthritis, , Treatment of adults with severe 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 nonsteroidal anti-inflammatory drugs (NSAIDs)., , Plaque psoriasis, , Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA)., , Paediatric plaque psoriasis, , Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies., | First Published (İlk Yayın Tarihi): | 6.02.2018 |
| Revision Date (Revizyon Tarihi): | 11 | Revision Date (Revizyon Tarihi): | 30.01.2020 |
| 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.
