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).

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

krka d.d. novo mesto d.d. - olmesartanmedoxomil 20 mg; amlodipinebesilaat 6,94 mg - eq. amlodipine 5 mg - filmomhulde tablet - 20 mg - 5 mg - olmesartanmedoxomil 20 mg; amlodipinebesilaat 6.94 mg - olmesartan medoxomil and amlodipine

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

krka d.d. novo mesto d.d. - olmesartanmedoxomil 40 mg; amlodipinebesilaat 13,88 mg - eq. amlodipine 10 mg - filmomhulde tablet - 40 mg - 10 mg - olmesartanmedoxomil 40 mg; amlodipinebesilaat 13.88 mg - olmesartan medoxomil and amlodipine

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

krka d.d. novo mesto d.d. - olmesartanmedoxomil 40 mg; amlodipinebesilaat 6,94 mg - eq. amlodipine 5 mg - filmomhulde tablet - 40 mg - 5 mg - olmesartanmedoxomil 40 mg; amlodipinebesilaat 6.94 mg - olmesartan medoxomil and amlodipine

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).

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

krka d.d., novo mesto - milbemycine oxime; praziquantel - tablet - milbemycine oxime 12,5 mg/stuk; praziquantel 125 mg/stuk, - milbemycin oxime, combinations - honden

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

krka d.d., novo mesto - milbemycine oxime; praziquantel - filmomhulde tablet - milbemycine oxime 16 mg/stuk; praziquantel 40 mg/stuk, - milbemycin oxime, combinations - katten

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

krka d.d., novo mesto - milbemycine oxime; praziquantel - tablet - milbemycine oxime 2,5 mg/stuk; praziquantel 25 mg/stuk, - milbemycin oxime, combinations - honden

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

krka d.d., novo mesto - milbemycine oxime; praziquantel - filmomhulde tablet - milbemycine oxime 4 mg/stuk; praziquantel 10 mg/stuk, - milbemycin oxime, combinations - katten

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

krka d.d., novo mesto - milbemycine oxime; praziquantel - tablet - milbemycine oxime 12,5 mg/stuk; praziquantel 125 mg/stuk, - milbemycin oxime, combinations - honden