| Medicine Name (İlaç Adı): | IntronA | Therapeutic Area (Terapötik Bölge): | Carcinoid Tumor, Leukemia, Hairy Cell, Lymphoma, Follicular, Hepatitis B, Chronic, Hepatitis C, Chronic, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Melanoma, Multiple Myeloma |
| Active Substance (Aktif Madde): | interferon alfa-2b | Product Number (Ürün Numarası): | EMEA/H/C/000281 |
| ATC Code (ATC Kodu): | L03AB05 | Authorisation Status (Yetkilendirme Durumu): | Authorised |
| International Non-Proprietary Name (INN) / Ortak İsim: | interferon alfa-2b | 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): | 9.03.2000 | Marketing Authorisation Holder/Company Name (Şirket Adı): | Merck Sharp & Dohme B.V. |
| Human Pharmacotherapeutic Group (İnsan Farmakoterapötik Grubu): | Immunostimulants, | Decision Date (Görüş Tarihi): | 20.12.2019 |
| Condition / İndication (Şart / Edikasyon): | Chronic hepatitis BTreatment of adult patients with chronic hepatitis B associated with evidence of hepatitis-B viral replication (presence of DNA of hepatitis-B virus (HBV-DNA) and hepatitis-B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and / or fibrosis.Chronic hepatitis CBefore initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon.Adult patientsIntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for hepatitis-C virus-RNA (HCV-RNA).The best way to use IntronA in this indication is in combination with ribavirin.Children three years of age and older and adolescentsIntronA is indicated, in a combination regimen with ribavirin, for the treatment of children three years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients.The decision to treat should be made on a case-by-case basis.Hairy-cell leukaemiaTreatment of patients with hairy cell leukaemia.Chronic myelogenous leukaemiaMonotherapyTreatment of adult patients with Philadelphia-chromosome- or bcr/abl-translocation-positive chronic myelogenous leukaemia.Clinical experience indicates that a haematological and cytogenetic major / minor response is obtainable in the majority of patients treated. A major cytogenetic response is defined by 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10 %, pyrexia > 38°C for more than eight days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.Carcinoid tumourTreatment of carcinoid tumours with lymph node or liver metastases and with 'carcinoid syndrome'.Malignant melanomaAs adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g. patients with primary or recurrent (clinical or pathological) lymph-node. | First Published (İlk Yayın Tarihi): | 28.09.2017 |
| Revision Date (Revizyon Tarihi): | 33 | Revision Date (Revizyon Tarihi): | 11.03.2020 |
| 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.
