Australien - engelska - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 30.25 mg - capsule - excipient ingredients: gelatin; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; purified talc; croscarmellose sodium; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - multiple myeloma (mm),lenalidomide-teva is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),lenalidomide-teva is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Europeiska unionen - engelska - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - immunosuppressants - 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 indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.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 and 5.1).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 indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.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 and 5.1).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).

USA - engelska - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem cell transplantation (auto-hsct). lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (mds) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. lenalidomide capsules in combination with a rituximab product, are indicated for the treatment of adult patients with previously treated follicular lymphoma (fl). lenalidomide capsules in combination with a rituximab product, are indicated for

USA - engelska - NLM (National Library of Medicine)

aurobindo pharma limited - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem cell transplantation (auto-hsct). lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (mds) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. lenalidomide capsules are not indicated and are not recommended for the treatment of patients with cll outside of controlled clinical trials [see warnings and precautions (5.5)] . lenalidomide can cause fetal harm when administered to a pregnant female. limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. this effect was seen at all doses tested. due to the results of this developme

USA - engelska - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem cell transplantation (auto-hsct). lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (mds) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.  lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (fl).  lenalidomide capsules in combination with a rituximab product, is indicated for

USA - engelska - NLM (National Library of Medicine)

teva pharmaceuticals, inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (mds) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. lenalidomide capsules are not indicated and are not recommended for the treatment of patients with cll outside of controlled clinical trials [see warnings and precautions (5.5)] . lenalidomide capsules can cause fetal harm when administered to a pregnant female. limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. this effect was seen at all

USA - engelska - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem cell transplantation (auto-hsct). lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (mds) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (fl). lenalidomide capsules in combination with a rituximab product, is indicated for th

Europeiska unionen - engelska - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - immunosuppressants - multiple myelomalenalidomide krka d.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.d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.lenalidomide krka d.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.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.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.d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.lenalidomide krka d.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.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).

USA - engelska - NLM (National Library of Medicine)

apotex corp. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem cell transplantation (auto-hsct). lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (mds) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (fl). lenalidomide capsules in combination with a rituximab product, is indicated for the

USA - engelska - NLM (National Library of Medicine)

exelan pharmaceuticals, inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (mm).    lenalidomide capsules are indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem cell transplantation (auto-hsct). lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes (mds) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (fl). lenalidomide capsules in combination with a rituximab product, is indicated