Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - angioödeem, pärilik - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - suhkurtõbi, tüüp 2 - diabeetis kasutatavad ravimid - 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 ja 5. 1 erinevate kombinatsioonide kohta kättesaadavate andmete osas).

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - antineoplastilised ained - 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - sclerosis multiplex, relapsing-remitting - immunosuppressants, valikuline immunosuppressants - 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).

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulants, - 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

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

Euroopa Liit - eesti - EMA (European Medicines Agency)

teva pharma b.v. - dotsetakseel - carcinoma, non-small-cell lung; breast neoplasms; prostatic neoplasms - antineoplastilised ained - rindade cancerdocetaxel teva pharma monotherapy on näidustatud ravi patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise rinnavähi pärast rikke tsütotoksiline ravi. eelmine keemiaravi peaks sisaldama antratsükliini või alküülivat ainet. non-small-cell lung cancerdocetaxel teva pharma on näidustatud ravi patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise mitte-small-cell lung cancer pärast rikke enne keemiaravi. docetaxel teva pharma koos cisplatin on näidustatud patsientide raviks unresectable, lokaalselt kaugelearenenud või metastaatilise mitte-small-cell lung cancer, patsientidel, kes ei ole varem saanud keemiaravi selle seisukord. eesnäärme cancerdocetaxel teva pharma kombinatsioonis prednisooni või prednisolooni on näidustatud patsientide raviks hormoon tulekindlad metastaatilise eesnäärmevähiga.

Euroopa Liit - eesti - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - astma - ravimid hingamisteede obstruktiivsete haiguste, - budesonide / formoterol teva pharma b. on näidustatud ainult 18-aastastel ja vanematel täiskasvanutel. asthmabudesonide/formoterol teva pharma b. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

Euroopa Liit - eesti - EMA (European Medicines Agency)

accord healthcare s.l.u. - deferasiroks - iron overload; beta-thalassemia - kõik muud ravi tooted, raua-kelaativad ained - deferasirox kokkuleppel on näidustatud ravi kroonilise raua ülekoormuse tõttu sagedasi vereülekandeid (≥7 ml/kg/kuus pakitud vere punaliblede) patsientidel beeta thalassaemia suur vanuses 6 aastat ja vanemad. deferasirox kokkuleppel on näidustatud ka ravi kroonilise raua ülekoormuse tõttu vereülekandeid, kui deferoksamiini ravi on vastunäidustatud või ebapiisav järgmised patsientide grupid:lastel patsientidel beeta thalassaemia suur raua ülekoormuse tõttu sagedasi vereülekandeid (≥7 ml/kg/kuus pakitud vere punaliblede), vanuses 2 kuni 5 aastat,täiskasvanud ja pediaatriliste patsientide beeta thalassaemia suur raua ülekoormuse tõttu harvad vereülekandeid (.