أيرلندا - الإنجليزية - HPRA (Health Products Regulatory Authority)

accord healthcare limited - rasagiline tartrate - tablets - 1 milligram - rasagiline - anti-parkinson-drugs, monoamine oxidase -b inhibitors - rasagiline accord is indicated for the treatment of idiopathic parkinson’s disease (pd) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

accord healthcare s.l.u. - abiraterone acetate - prostatic neoplasms - endocrine therapy - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - sumatriptan succinate -

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

accord healthcare s.l.u. - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. aripiprazole accord is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. aripiprazole accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.,

الاتحاد الأوروبي - الإنجليزية - 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.

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

accord healthcare s.l.u. - capecitabine - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastic agents - capecitabine accord is indicated for the adjuvant treatment of patients following surgery of stage-iii (dukes’ stage-c) colon cancer.capecitabine accord is indicated for the treatment of metastatic colorectal cancer.capecitabine accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.capecitabine accord in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline.capecitabine accord is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

accord healthcare s.l.u. - docetaxel - head and neck neoplasms, carcinoma, non-small-cell lung, adenocarcinoma, prostatic neoplasms, breast neoplasms - antineoplastic agents, - breast cancerdocetaxel accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.for patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.docetaxel accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.docetaxel accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. previous chemotherapy should have included an anthracycline or an alkylating agent.docetaxel accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer w

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

accord healthcare s.l.u. - eptifibatide - myocardial infarction - antithrombotic agents - eptifibatide accord is intended for use with acetylsalicylic acid and unfractionated heparin.eptifibatide accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ecg) changes and/or elevated cardiac enzymes.patients most likely to benefit from eptifibatide accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early ptca (percutaneous transluminal coronary angioplasty).

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment.- adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.- adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy.- adult patients with relapsed or refractory ph+ all as monotherapy.- adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements.- adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement.- adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.- the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).- the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined.in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5.1). except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.  

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

accord healthcare s.l.u. - voriconazole - aspergillosis; candidiasis; mycoses - antimycotics for systemic use, triazole derivatives - voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows:treatment of invasive aspergillosis;treatment of candidaemia in non-neutropenic patients;treatment of fluconazole-resistant serious invasive candida infections (including c. krusei);treatment of serious fungal infections caused by scedosporium spp. and fusarium spp.voriconazole accord should be administered primarily to patients with progressive, possibly life-threatening infections.