Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - carmustine, quantity: 100 mg - diluent, not applicable - excipient ingredients: ethanol absolute - carmustine accord is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:,1. malignant glioma,2. multiple myeloma - in combination with prednisone.,3. hodgkin?s disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.,4. non-hodgkin?s lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

Եվրոպական Միություն - անգլերեն - EMA (European Medicines Agency)

accord healthcare s.l.u. - bortezomib - multiple myeloma - antineoplastic agents - bortezomib accord as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.bortezomib accord in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high‑dose chemotherapy with haematopoietic stem cell transplantation.bortezomib accord in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high‑dose chemotherapy with haematopoietic stem cell transplantation.bortezomib accord in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine accord is indicated for the treatment of patients with,? intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), ,? chronic myelomonocytic leukemia (cmmol (10-29 percent marrow blasts without myeloproliferative disorder)), ,? acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), ,in whom allogenic stem cell transplantation is not indicated.

Մալթա - անգլերեն - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - abacavir, lamivudine - film-coated tablet - abacavir 600 mg lamivudine 300 mg - antivirals for systemic use

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - bortezomib, quantity: 3.5 mg - injection, solution - excipient ingredients: mannitol; water for injections - bortezomib accord, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib accord, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib accord is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib accord in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - bortezomib, quantity: 2.5 mg - injection, solution - excipient ingredients: mannitol; water for injections - bortezomib accord, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib accord, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib accord is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib accord in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Եվրոպական Միություն - անգլերեն - EMA (European Medicines Agency)

accord healthcare s.l.u. - pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesotheliomapemetrexed accord in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed accord in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.pemetrexed accord is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.pemetrexed accord is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - busulfan, quantity: 60 mg - injection, concentrated - excipient ingredients: macrogol 400; dimethylacetamide - busulfan accord is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - topotecan hydrochloride, quantity: 1.09 mg (equivalent: topotecan, qty 1 mg) - injection, concentrated - excipient ingredients: tartaric acid; hydrochloric acid; sodium hydroxide; water for injections - topotecan accord is indicated as single agent therapy for the treatment of patients with:,? small cell lung carcinoma after failure of first line chemotherapy.,? metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.,topotecan accord is indicated in combination with cisplatin for the treatment of patients with:,? histologically confirmed stage iv-b, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - topotecan hydrochloride, quantity: 4.346 mg (equivalent: topotecan, qty 4 mg) - injection, concentrated - excipient ingredients: hydrochloric acid; sodium hydroxide; water for injections; tartaric acid - topotecan accord is indicated as single agent therapy for the treatment of patients with:,? small cell lung carcinoma after failure of first line chemotherapy.,? metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.,topotecan accord is indicated in combination with cisplatin for the treatment of patients with:,? histologically confirmed stage iv-b, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.