Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 18.15 mg - capsule - excipient ingredients: microcrystalline cellulose; indigo blue; titanium dioxide; croscarmellose sodium; gelatin; purified talc; colloidal anhydrous silica; 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 12.1 mg - capsule - excipient ingredients: colloidal anhydrous silica; gelatin; croscarmellose sodium; iron oxide yellow; purified talc; microcrystalline cellulose; titanium dioxide; 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 6.05 mg - capsule - excipient ingredients: colloidal anhydrous silica; gelatin; purified talc; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; 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.

Australia - English - 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.

European Union - English - 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).

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 9.075 mg - capsule - excipient ingredients: gelatin; croscarmellose sodium; purified talc; titanium dioxide; colloidal anhydrous silica; microcrystalline cellulose; 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 24.2 mg - capsule - excipient ingredients: croscarmellose sodium; indigo blue; colloidal anhydrous silica; microcrystalline cellulose; gelatin; titanium dioxide; purified talc; 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 3.025 mg - capsule - excipient ingredients: colloidal anhydrous silica; gelatin; purified talc; croscarmellose sodium; indigo blue; titanium dioxide; iron oxide yellow; microcrystalline cellulose; 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.

European Union - English - 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).

Canada - English - Health Canada

teva canada limited - lenalidomide (lenalidomide hydrochloride monohydrate) - capsule - 2.5mg - lenalidomide (lenalidomide hydrochloride monohydrate) 2.5mg