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).

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

joint stock company grindeks - lenalidomide ammoniumchloride 3,016 mg - eq. lenalidomide 2,5 mg - capsule, hard - 2,5 mg - lenalidomide ammoniumchloride 3.016 mg - lenalidomide

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

joint stock company grindeks - lenalidomide ammoniumchloride 6,032 mg - eq. lenalidomide 5 mg - capsule, hard - 5 mg - lenalidomide ammoniumchloride 6.032 mg - lenalidomide

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

joint stock company grindeks - lenalidomide ammoniumchloride 9,048 mg - eq. lenalidomide 7,5 mg - capsule, hard - 7,5 mg - lenalidomide ammoniumchloride 9.048 mg - lenalidomide

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

joint stock company grindeks - lenalidomide ammoniumchloride 12,064 mg - eq. lenalidomide 10 mg - capsule, hard - 10 mg - lenalidomide ammoniumchloride 12.064 mg - lenalidomide

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

joint stock company grindeks - lenalidomide ammoniumchloride 18,096 mg - eq. lenalidomide 15 mg - capsule, hard - 15 mg - lenalidomide ammoniumchloride 18.096 mg - lenalidomide

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

joint stock company grindeks - lenalidomide ammoniumchloride 24,128 mg - eq. lenalidomide 20 mg - capsule, hard - 20 mg - lenalidomide ammoniumchloride 24.128 mg - lenalidomide

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

joint stock company grindeks - lenalidomide ammoniumchloride 30,16 mg - eq. lenalidomide 25 mg - capsule, hard - 25 mg - lenalidomide ammoniumchloride 30.16 mg - lenalidomide

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

medac pharma s.r.l. - lenalidomidehydrochloride 1-water samenstelling overeenkomend met ; lenalidomide - capsule, hard - ammonia (e 527) ; cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; gelatine (e 441) ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; indigokarmijn (e 132) ; kaliumhydroxide (e 525) ; propyleenglycol (e 1520) ; schellak (e 904) ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171) ; zwarte inkt - lenalidomide

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

medac pharma s.r.l. - lenalidomidehydrochloride 1-water samenstelling overeenkomend met ; lenalidomide - capsule, hard - ammonia (e 527) ; cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; gelatine (e 441) ; ijzeroxide zwart (e 172) ; indigokarmijn (e 132) ; kaliumhydroxide (e 525) ; propyleenglycol (e 1520) ; schellak (e 904) ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171) ; zwarte inkt - lenalidomide