Plerixafor Accord Unión Europea - estonio - EMA (European Medicines Agency)

plerixafor accord

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.

Pemetrexed Baxter Unión Europea - estonio - EMA (European Medicines Agency)

pemetrexed baxter

baxter holding b.v. - pemetrexed disodium heptahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastilised ained - malignant pleural mesotheliomapemetrexed baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed baxter 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 (see section 5. pemetrexed baxter 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 (see section 5. pemetrexed baxter 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 (see section 5.

Teriparatide Sun Unión Europea - estonio - EMA (European Medicines Agency)

teriparatide sun

sun pharmaceutical industries europe b.v. - teriparatiid - osteoporosis; osteoporosis, postmenopausal - kaltsiumi homöostaas - teriparatide sun is indicated in adults. treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.

Kauliv Unión Europea - estonio - EMA (European Medicines Agency)

kauliv

strides pharma (cyprus) limited - teriparatiid - osteoporosis; osteoporosis, postmenopausal - kaltsiumi homöostaas - kauliv is indicated in adults. treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.

Yesafili Unión Europea - estonio - EMA (European Medicines Agency)

yesafili

viatris limited - aflibercept - macular edema; retinal vein occlusion; diabetic retinopathy; myopia, degenerative; diabetes complications - oftalmoloogilised vahendid - yesafili is indicated for adults for the treatment ofneovascular (wet) age-related macular degeneration (amd) (see section 5. 1),visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo) (see section 5. 1),visual impairment due to diabetic macular oedema (dme) (see section 5. 1),visual impairment due to myopic choroidal neovascularisation (myopic cnv) (see section 5.

Adcirca (previously Tadalafil Lilly) Unión Europea - estonio - EMA (European Medicines Agency)

adcirca (previously tadalafil lilly)

eli lilly nederland b.v. - tadalafiil - hüpertensioon, kopsuvähk - uroloogilised ravimid - adultstreatment of pulmonary arterial hypertension (pah) classified as who functional class ii and iii, to improve exercise capacity (see section 5. efektiivsust on näidatud idiopaatiliste pah-de (ipah) ja kollageen-vaskulaarhaigusega seotud pah-de puhul. paediatric populationtreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (pah) classified as who functional class ii and iii.

Aripiprazole Zentiva Unión Europea - estonio - EMA (European Medicines Agency)

aripiprazole zentiva

zentiva, k.s. - aripiprasool - schizophrenia; bipolar disorder - psühhoeptikumid - aripiprasool zentiva on näidustatud skisofreenia raviks täiskasvanutel ja noorukitel vanuses 15 aastat ja vanemad. aripiprasool zentiva on näidustatud ravi mõõduka kuni raske maniakaalse episoodi bipolaarne i häire ja ennetamise ning uue maniakaalse episoodi täiskasvanutel, kes on kogenud peamiselt maniakaalsed episoodid ja kelle maniakaalsed episoodid vastas, et aripiprasool ravi. aripiprasool zentiva on näidustatud ravi kuni 12 nädala jooksul mõõduka kuni raske maniakaalse episoodi bipolaarne i häire noorukitel vanuses 13 aastat ja vanemad.

Aubagio Unión Europea - estonio - EMA (European Medicines Agency)

aubagio

sanofi winthrop industrie - teriflunomide - hulgiskleroos - selektiivsed immunosupressandid - aubagio 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).