Unione Europea - maltese - EMA (European Medicines Agency)

accord healthcare s.l.u. - relugolix - neoplasmi prostatiċi - terapija endokrinali - orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.

Unione Europea - maltese - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Unione Europea - maltese - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Unione Europea - maltese - EMA (European Medicines Agency)

accord healthcare s.l.u. - leuprorelin mesilate - neoplasmi prostatiċi - terapija endokrinali - camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

Unione Europea - maltese - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriparatide - l-osteoporożi - homeostasi tal-kalċju - sondelbay is indicated in adults. trattament ta 'l-osteoporożi f'nisa wara l-menopawża u fl-irġiel b'riskju akbar ta' ksur. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. trattament ta 'osteoporożi assoċjat ma sostnut sistemika terapija bi glukokortikojdi f'nisa u l-irġiel f'riskju akbar ta' ksur.

Unione Europea - maltese - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus:it is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. it is indicated in combination with a sulphonylurea (i. , terapija ta 'kumbinazzjoni tripla) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u sulphonylurea. it is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. it is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Unione Europea - maltese - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - aġenti antineoplastiċi - hepatocellular carcinomasorafenib accord is indicated for the treatment of hepatocellular carcinoma (see section 5. renal cell carcinomasorafenib accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

Unione Europea - maltese - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti, selettiv immunosuppressanti - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Unione Europea - maltese - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulanti, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Unione Europea - maltese - EMA (European Medicines Agency)

accord healthcare s.l.u. - dimetil fumarate - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosoppressanti - dimethyl fumarate accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).