Singapore - engelska - HSA (Health Sciences Authority)

bristol-myers squibb (singapore) pte. ltd. - lenalidomide - capsule - 25.0 mg - lenalidomide 25.0 mg

Singapore - engelska - HSA (Health Sciences Authority)

bristol-myers squibb (singapore) pte. ltd. - lenalidomide - capsule - 5.0 mg - lenalidomide 5.0 mg

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

janssen-cilag pty ltd - daratumumab, quantity: 400 mg - injection, concentrated - excipient ingredients: glacial acetic acid; sodium acetate trihydrate; sodium chloride; mannitol; polysorbate 20; water for injections - darzalex is indicated for the treatment of patients:,? with newly diagnosed multiple myeloma:,- who are eligible for autologous stem cell transplant. for use in combination with:,? bortezomib, thalidomide, and dexamethasone.,- who are ineligible for autologous stem cell transplant. for use in combination with:,? bortezomib, melphalan and prednisone, or,? lenalidomide and dexamethasone.,? with multiple myeloma who have received:,- at least one prior therapy. for use in combination with:,? bortezomib and dexamethasone, or,? lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent. for use as:,? monotherapy.

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

janssen-cilag pty ltd - daratumumab, quantity: 100 mg - injection, concentrated - excipient ingredients: glacial acetic acid; sodium acetate trihydrate; sodium chloride; mannitol; polysorbate 20; water for injections - darzalex is indicated for the treatment of patients:,? with newly diagnosed multiple myeloma:,- who are eligible for autologous stem cell transplant. for use in combination with:,? bortezomib, thalidomide, and dexamethasone.,- who are ineligible for autologous stem cell transplant. for use in combination with:,? bortezomib, melphalan and prednisone, or,? lenalidomide and dexamethasone.,? with multiple myeloma who have received:,- at least one prior therapy. for use in combination with:,? bortezomib and dexamethasone, or,? lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent. for use as:,? monotherapy.

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - daratumumab 20 mg/ml;  ;   - concentrate for infusion - 100 mg/5ml - active: daratumumab 20 mg/ml     excipient: glacial acetic acid mannitol polysorbate 20 sodium acetate trihydrate sodium chloride water for injection - darzalex is indicated for the treatment of patients: with newly diagnosed multiple myeloma: - who are eligible for autologous stem cell transplant. for use in combination with: - bortezomib, thalidomide, and dexamethasone. - who are ineligible for autologous stem cell transplant. for use in combination with: - bortezomib, melphalan and prednisone, or - lenalidomide and dexamethasone with multiple myeloma who have received: - at least one prior therapy. for use in combination with: - bortezomib and dexamethasone, or - lenalidomide and dexamethasone. - at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent for use as: - monotherapy

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - daratumumab 20 mg/ml;  ;   - concentrate for infusion - 400 mg/20ml - active: daratumumab 20 mg/ml     excipient: glacial acetic acid mannitol polysorbate 20 sodium acetate trihydrate sodium chloride water for injection - darzalex is indicated for the treatment of patients: with newly diagnosed multiple myeloma: - who are eligible for autologous stem cell transplant. for use in combination with: - bortezomib, thalidomide, and dexamethasone. - who are ineligible for autologous stem cell transplant. for use in combination with: - bortezomib, melphalan and prednisone, or - lenalidomide and dexamethasone with multiple myeloma who have received: - at least one prior therapy. for use in combination with: - bortezomib and dexamethasone, or - lenalidomide and dexamethasone. - at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent for use as: - monotherapy

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - daratumumab 120 mg/ml;   - solution for injection - 1800 mg/15ml - active: daratumumab 120 mg/ml   excipient: histidine histidine hydrochloride monohydrate hyaluronidase methionine polysorbate 20 sorbitol water for injection - darzalex sc is indicated for the treatment of adult patients (18 years and over): - with newly diagnosed multiple myeloma: - who are eligible for autologous stem cell transplant. for use in combination with: bortezomib, thalidomide, and dexamethasone. - who are ineligible for autologous stem cell transplant. for use in combination with: bortezomib, melphalan and prednisone, or lenalidomide and dexamethasone. -with multiple myeloma who have received: - at least one prior therapy. for use in combination with: bortezomib and dexamethasone, or lenalidomide and dexamethasone. - at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent. for use as: monotherapy.

Irland - engelska - HPRA (Health Products Regulatory Authority)

aspire pharma limited - bortezomib - powder for solution for injection - 1 milligram(s) - other antineoplastic agents; bortezomib

Irland - engelska - HPRA (Health Products Regulatory Authority)

teva b.v. - bortezomib - powder for solution for injection - 2.5 milligram(s) - bortezomib

Irland - engelska - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - bortezomib - powder for solution for injection - 1 milligram(s) - bortezomib