Lenalidomide Krka d.d. (lenalidomide)
Lenalidomide Krka d.d. is a medicine used for the treatment of certain cancers and serious conditions affecting blood cells and bone marrow, namely multiple myeloma, myelodysplastic syndromes and follicular lymphoma.
In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Krka d.d. is used:
- in adults with previously untreated (newly diagnosed) multiple myeloma, who have had an autologous stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced with the patient’s own stem cells to form new bone marrow);
- in adults with previously untreated multiple myeloma, who cannot have stem cell transplantation. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone;
- in adults whose disease has been treated at least once. It is used in combination with dexamethasone.
In myelodysplastic syndromes, a group of bone marrow disorders that cause anaemia (low red blood cell counts), Lenalidomide Krka d.d. is used in patients who need blood transfusions to manage their anaemia. It is used in patients with a genetic change (called deletion 5q) when other treatments are not adequate.
In follicular lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide Krka d.d. is used in adults whose disease has come back after treatment or does not improve with treatment. It is used in combination with rituximab.
Date of MA: 11/02/2021
MA holder: Krka, d.d., Novo mesto
Lenalidomide Krka d.d. Novo mesto (lenalidomide)
Lenalidomide Krka d.d. Novo mesto is a medicine used for the treatment of certain cancers and serious conditions affecting blood cells and bone marrow, namely multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma.
In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Krka d.d. Novo mesto is used:
- in adults with previously untreated (newly diagnosed) multiple myeloma, who have had an autologous stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced with the patient’s own stem cells to form new bone marrow);
- in adults with previously untreated multiple myeloma, who cannot have stem cell transplantation. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone;
- in adults whose disease has been treated at least once. It is used in combination with dexamethasone.
In myelodysplastic syndromes, a group of bone marrow disorders that cause anaemia (low red blood cell counts), Lenalidomide Krka d.d. Novo mesto is used in patients who need blood transfusions to manage their anaemia. It is used in patients with a genetic change (called deletion 5q) when other treatments are not adequate.
In mantle cell lymphoma and follicular lymphoma, blood cancers that affect a type of white blood cell called B lymphocytes, Lenalidomide Krka d.d. Novo mesto is used in adults whose disease has come back after treatment or does not improve with treatment. In follicular lymphoma it is used in combination with rituximab.
Date of MA: 11/02/2021
MA holder: Krka, d.d., Novo mesto
Lenalidomide Krka (lenalidomide)
Lenalidomide Krka is a medicine used for the treatment of certain cancers affecting blood cells, namely multiple myeloma and follicular lymphoma.
In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Krka is used:
- in adults with previously untreated (newly diagnosed) multiple myeloma, who have had an autologous stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced with the patient’s own stem cells to form new bone marrow);
- in adults with previously untreated multiple myeloma, who cannot have stem cell transplantation. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone;
- in adults whose disease has been treated at least once. It is used in combination with dexamethasone.
In follicular lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide Krka is used in adults whose disease has come back after treatment or does not improve with treatment. It is used in combination with rituximab.
Date of MA: 11/02/2021
MA holder: Krka, d.d., Novo mesto
Yuflyma (adalimumab)
- Polyarticular juvenile idiopathic arthritis : Yuflyma in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
- Enthesitis-related arthritis : Yuflyma is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.
- Uveitis : Yuflyma is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate.
- Paediatric uveitis : Yuflyma is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Date of MA:11/02/2021
MA holder: Celltrion Healthcare Hungary Kft.
Onbevzi (bevacizumab)
Onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.
Onbevzi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Onbevzi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents.
Onbevzi, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents.
Onbevzi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.
Date of MA:11/02/2021
MA holder: Celltrion Healthcare Hungary Kft.
