| Medicine Name (İlaç Adı): | RoActemra | Therapeutic Area (Terapötik Bölge): | Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid |
| Active Substance (Aktif Madde): | tocilizumab | Product Number (Ürün Numarası): | EMEA/H/C/000955 |
| ATC Code (ATC Kodu): | L04AC07 | Authorisation Status (Yetkilendirme Durumu): | Authorised |
| International Non-Proprietary Name (INN) / Ortak İsim: | tocilizumab | 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): | 15.01.2009 | Marketing Authorisation Holder/Company Name (Şirket Adı): | Roche Registration GmbH |
| Human Pharmacotherapeutic Group (İnsan Farmakoterapötik Grubu): | Immunosuppressants | Decision Date (Görüş Tarihi): | 17.10.2019 |
| Condition / İndication (Şart / Edikasyon): | RoActemra, in combination with methotrexate (MTX), is indicated for:the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.RoActemra, in combination with methotrexate (MTX), is indicated for:the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. | First Published (İlk Yayın Tarihi): | 12.04.2018 |
| Revision Date (Revizyon Tarihi): | 29 | Revision Date (Revizyon Tarihi): | 14.11.2019 |
| 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.
