Kesatuan Eropah - Jerman - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - immunsuppressiva - multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) ist indiziert für die behandlung erwachsener patienten mit zuvor unbehandeltem multiplen myelom, die nicht die voraussetzungen für eine transplantation. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) ist indiziert für die behandlung erwachsener patienten mit zuvor unbehandeltem multiplen myelom, die nicht die voraussetzungen für eine transplantation. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Kesatuan Eropah - Jerman - EMA (European Medicines Agency)

novartis europharm limited  - siponimod fumarsäure - multiple sklerose, schubförmig-remittierender - selektive immunsuppressiva - mayzent ist indiziert für die behandlung von erwachsenen patienten mit sekundär progredienter multipler sklerose (spms) mit aktiver erkrankung, belegt durch rückfälle oder imaging-funktionen von der entzündlichen aktivität.

Jerman - Jerman - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

eugia pharma (malta) limited (1010127) - lenalidomid - hartkapsel - 5 mg - teil 1 - hartkapsel; lenalidomid (32806) 5 milligramm

Jerman - Jerman - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

eugia pharma (malta) limited (1010127) - lenalidomid - hartkapsel - 25 mg - teil 1 - hartkapsel; lenalidomid (32806) 25 milligramm

Jerman - Jerman - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

eugia pharma (malta) limited (1010127) - lenalidomid - hartkapsel - 10 mg - teil 1 - hartkapsel; lenalidomid (32806) 10 milligramm

Jerman - Jerman - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

eugia pharma (malta) limited (1010127) - lenalidomid - hartkapsel - 20 mg - teil 1 - hartkapsel; lenalidomid (32806) 20 milligramm

Jerman - Jerman - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

eugia pharma (malta) limited (1010127) - lenalidomid - hartkapsel - 2,5 mg - teil 1 - hartkapsel; lenalidomid (32806) 2,5 milligramm

Jerman - Jerman - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

eugia pharma (malta) limited (1010127) - lenalidomid - hartkapsel - 7,5 mg - teil 1 - hartkapsel; lenalidomid (32806) 7,5 milligramm

Jerman - Jerman - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

eugia pharma (malta) limited (1010127) - lenalidomid - hartkapsel - 15 mg - teil 1 - hartkapsel; lenalidomid (32806) 15 milligramm

Kesatuan Eropah - Jerman - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - transplantatabstoßung - immunsuppressiva - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.