Europese Unie - Nederlands - EMA (European Medicines Agency)

baxter holding b.v. - doxorubicine hydrochloride - sarcoma, kaposi; multiple myeloma; ovarian neoplasms; breast neoplasms - antineoplastische middelen - caelyx gepegyleerd liposomaal is aangegeven:als monotherapie bij patiënten met gemetastaseerde borstkanker, waar sprake is van een verhoogde cardiale risico ' s;voor de behandeling van gevorderde eierstokkanker bij vrouwen die niet in een eerste-lijn op platina gebaseerde chemotherapie regime;in combinatie met bortezomib voor de behandeling van progressieve multiple myeloom bij patiënten die ten minste één eerdere therapie en die al hebben ondergaan, of zijn niet geschikt voor beenmergtransplantatie;voor de behandeling van aids-gerelateerde kaposi sarcoom (ks) bij patiënten met lage cd4-tellingen (.

Europese Unie - Nederlands - EMA (European Medicines Agency)

pharmaand gmbh - watervrij panobinostatlactaat - multiple myeloma - antineoplastische middelen - farydak, is in combinatie met bortezomib en dexamethason, geïndiceerd voor de behandeling van volwassen patiënten met recidiverende en/of vuurvaste multipel myeloom die ten minste twee voorafgaande regimes met inbegrip van bortezomib en immunomodulerende agent hebben ontvangen. farydak, is in combinatie met bortezomib en dexamethason, geïndiceerd voor de behandeling van volwassen patiënten met recidiverende en/of vuurvaste multipel myeloom die ten minste twee voorafgaande regimes met inbegrip van bortezomib en immunomodulerende agent hebben ontvangen.

Europese Unie - Nederlands - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - pomalidomide - multiple myeloma - immunosuppressiva - imnovid in combinatie met bortezomib en dexamethason is geïndiceerd voor de behandeling van volwassen patiënten met multipel myeloom die op zijn minst een voorafgaande behandeling regime, met inbegrip van lenalidomide. imnovid in combinatie met dexamethason is geïndiceerd in de behandeling van volwassen patiënten met recidiverende en vuurvaste multipel myeloom die ten minste twee voorafgaande behandeling regimes, met inbegrip van lenalidomide zowel bortezomib, hebben ontvangen en hebben aangetoond dat progressie van de ziekte op de laatste therapie.

Europese Unie - Nederlands - EMA (European Medicines Agency)

stemline therapeutics b.v. - selinexor - multiple myeloma - antineoplastische middelen - nexpovio is indicatedin combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Europese Unie - Nederlands - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Europese Unie - Nederlands - EMA (European Medicines Agency)

yes pharmaceutical development services gmbh - doxorubicine hydrochloride - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - antineoplastische middelen - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Europese Unie - Nederlands - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - lenalidomide - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - immunosuppressiva - meerdere myelomarevlimid als monotherapie is geïndiceerd voor het onderhoud behandeling van volwassen patiënten met nieuw gediagnosticeerde multipel myeloom die hebben ondergaan autologe stamcel transplantatie. revlimid als combinatie therapie met dexamethason, of bortezomib en dexamethason, of melfalan en prednison (zie sectie 4. 2) is geïndiceerd voor de behandeling van volwassen patiënten met eerder behandelde multipel myeloom die niet in aanmerking komen voor transplantatie. revlimid in combinatie met dexamethason is geïndiceerd voor de behandeling van multipel myeloom bij volwassen patiënten die minstens één eerdere therapie. myelodysplastisch syndromesrevlimid als monotherapie is geïndiceerd voor de behandeling van volwassen patiënten met transfusie-afhankelijke anemie als gevolg van een laag - of gemiddelde-1-risico myelodysplastische syndromen geassocieerd met een geïsoleerde verwijdering 5q cytogenetische afwijking bij andere therapeutische opties zijn onvoldoende of verkeerde. mantel cel lymphomarevlimid als monotherapie is geïndiceerd voor de behandeling van volwassen patiënten met recidief of refractair mantelcellymfoom. folliculaire lymphomarevlimid in combinatie met rituximab (anti-cd20 antistof) is geïndiceerd voor de behandeling van volwassen patiënten met, eerder behandelde folliculair lymfoom (grade 1 – 3a).

Europese Unie - Nederlands - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - immunosuppressiva - 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) is geïndiceerd voor de behandeling van volwassen patiënten met eerder behandelde multipel myeloom die niet in aanmerking komen voor transplantatie. 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) is geïndiceerd voor de behandeling van volwassen patiënten met eerder behandelde multipel myeloom die niet in aanmerking komen voor transplantatie. 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).

Europese Unie - Nederlands - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - immunosuppressiva - multiple myelomalenalidomide krka 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 as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is geïndiceerd voor de behandeling van volwassen patiënten met eerder behandelde multipel myeloom die niet in aanmerking komen voor transplantatie. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 en 5. follicular lymphomalenalidomide krka 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 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 as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is geïndiceerd voor de behandeling van volwassen patiënten met eerder behandelde multipel myeloom die niet in aanmerking komen voor transplantatie. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 en 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).