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. - cinacalcet hydrochloride - hyperparathyroidism - calcium homeostasis - secondary hyperparathyroidismadultstreatment of secondary hyperparathyroidism (hpt) in adult patients with end-stage renal disease (esrd) on maintenance dialysis therapy.paediatric populationtreatment of secondary hyperparathyroidism (hpt) in children aged 3 years and older with end-stage renal disease (esrd) on maintenance dialysis therapy in whom secondary hpt is not adequately controlled with standard of care therapy (see section 4.4).cinacalcet accordpharma may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols, as appropriate (see section 5.1).parathyroid carcinoma and primary hyperparathyroidism in adultsreduction of hypercalcaemia in adult patients with:parathyroid carcinoma.primary hpt for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

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

أيرلندا - الإنجليزية - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - daptomycin - powder for solution for injection/infusion - daptomycin

أيرلندا - الإنجليزية - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - daptomycin - powder for solution for injection/infusion - daptomycin

الاتحاد الأوروبي - الإنجليزية - 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.

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

accord healthcare s.l.u. - entecavir - hepatitis b, chronic - antivirals for systemic use - entecavir accord is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis., decompensated liver disease. , for both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with hbeag positive and hbeag negative hbv infection. with respect to patients with lamivudine-refractory hepatitis b. entecavir accord is also indicated for the treatment of chronic hbv infection in nucleoside naive paediatric patients from 2 to

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - diabetes mellitus, type 2 - drugs used in diabetes - vildagliptin/metformin hydrochloride accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:- in patients who are inadequately controlled with metformin hydrochloride alone.- in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets.- in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

accord healthcare s.l.u. - pramipexole dihydrochloride monohydrate - parkinson disease; restless legs syndrome - anti-parkinson drugs - pramipexole accord is indicated in adults for treatment of the signs and symptoms of idiopathic parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).