| Medicine Name (İlaç Adı): | Viread | Therapeutic Area (Terapötik Bölge): | Hepatitis B, Chronic, HIV Infections |
| Active Substance (Aktif Madde): | tenofovir disoproxil fumarate | Product Number (Ürün Numarası): | EMEA/H/C/000419 |
| ATC Code (ATC Kodu): | J05AF07 | Authorisation Status (Yetkilendirme Durumu): | Authorised |
| International Non-Proprietary Name (INN) / Ortak İsim: | tenofovir disoproxil | 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): | 4.02.2002 | Marketing Authorisation Holder/Company Name (Şirket Adı): | Gilead Sciences Ireland UC |
| Human Pharmacotherapeutic Group (İnsan Farmakoterapötik Grubu): | Antivirals for systemic use, | Decision Date (Görüş Tarihi): | 8.04.2019 |
| Condition / İndication (Şart / Edikasyon): | HIV 1 infection, , Viread 123 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg., The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.Hepatitis B infection, , Viread 123 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 17 kg to less than 22 kg, with, , compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1., HIV 1 infection, , Viread 163 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 22 kg to less than 28 kg., The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.Hepatitis B infection, , Viread 163 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 22 kg to less than 28 kg, with:, , compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1., HIV 1 infection, , Viread 204 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 28 kg to less than 35 kg., The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.Hepatitis B infection, , Viread 204 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 28 kg to less than 35 kg, with:, , compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1., HIV 1 infection, , Viread 245 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults., In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml)., Viread 245 mg film coated tablets are also indicated for the treatment of HIV 1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years., The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.Hepatitis B infection, , Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adults with:, , compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1)., evidence of lamivudine resistant hepatitis B virus (see sections 4.8 and 5.1)., decompensated liver disease (see sections 4.4, 4.8 and 5.1)., Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:, , compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1., HIV 1 infection, , Viread 33 mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate., Viread 33 mg/g granules are also indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults for whom a solid dosage form is not appropriate., In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml)., The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients., , Hepatitis B infection, Viread 33 mg/g granules are indicated for the treatment of chronic hepatitis B in adults for whom a solid dosage form is not appropriate with:, , compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1)., evidence of lamivudine resistant hepatitis B virus (see sections 4.8 and 5.1)., decompensated liver disease (see sections 4.4, 4.8 and 5.1)., , Viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis B in paediatric patients2 to < 18 years of age for whom a solid dosage form is not appropriate with:, , compensated liver disease and evidence of immune active disease, i.e. active viral replication, and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1., | First Published (İlk Yayın Tarihi): | 19.07.2018 |
| Revision Date (Revizyon Tarihi): | 52 | Revision Date (Revizyon Tarihi): | 16.05.2019 |
| 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.
