Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - majloma multipla - aġenti antineoplastiċi - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

sanofi pasteur - sars-cov-2 prefusion spike delta tm protein, recombinant (b.1.351 strain) - covid-19 virus infection - vaċċini - vidprevtyn beta is indicated as a booster for active immunisation to prevent covid-19 in adults who have previously received an mrna or adenoviral vector covid-19 vaccine (see sections 4. 2 u 5. 1 in product information document). l-użu ta ' dan il-vaċċin għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - teriparatide - osteoporosis; osteoporosis, postmenopausal - homeostasi tal-kalċju - 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.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

strides pharma (cyprus) limited - teriparatide - osteoporosis; osteoporosis, postmenopausal - homeostasi tal-kalċju - 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.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

hipra human health s.l. - sars-cov-2 virus recombinant spike (s) protein receptor binding domain (rbd) fusion heterodimer – b.1.351-b.1.1.7 strains - covid-19 virus infection - vaċċini - bimervax is indicated as a booster for active immunisation to prevent covid-19 in individuals 16 years of age and older who have previously received a mrna covid-19 vaccine.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

novartis europharm ltd. - l-amlodipina, valsartan, hydrochlorothiazide - pressjoni għolja - antagonisti ta 'angiotensin ii, sempliċi, antagonisti ta' angiotensin ii, kombinazzjonijiet - trattament ta ' l-ipertensjoni essenzjali bħala terapija ta ' sostituzzjoni fil-pazjenti adulti l-pressjoni tad-demm tagħhom huwa kontrollat adegwatament dwar il-kombinazzjoni ta ' amlodipine, valsartan u idrochlorothiazide (hct), meħuda bħala tliet formulazzjonijiet ta ' wieħed il-komponent jew bħala a doppju-komponent u formulazzjoni wieħed-komponent.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

ratiopharm gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulanti, - filgrastim ratiopharm huwa indikat għat-tnaqqis fit-tul tal-neutropenia u l-inċidenza tal-marda bid-deni neutropenia fil-pazjenti trattati bil-stabbilit chemotherapy ċitotossiċi għall-malignancy (bl-eċċezzjoni tal-lewċemja myeloid kronika u myelodysplastic sindromi) u għat-tnaqqis fit-tul tal-neutropenia fil-pazjenti sottoposti għal terapija myeloablative segwit mill-mudullun trapjant meqjusa li huma f'riskju akbar ta ' neutropenia ħorox imtawla. is-sigurtà u l-effikaċja ta 'filgrastim huma simili fl-adulti u fit-tfal li qed jirċievu kimoterapija ċitotossika. filgrastim ratiopharm huwa indikat għall-mobilizzazzjoni tal-taċ-ċelluli proġenitriċi tad-demm periferali (pbpc). f'pazjenti, tfal jew adulti, b'severa konġenitali, ċiklika, jew newtropenja idjopatika bl-għadd assolut ta 'newtrofili (anc) ta' 0. 5 x 109/l, u storja ta ' l-infezzjonijiet serji jew rikorrenti, amministrazzjoni għal żmien twil ta filgrastim ratiopharm huwa indikat biex iżidu l-għadd ta ' neutrophil u biex titnaqqas l-inċidenza u t-tul ta ' avvenimenti relatati ma ' l-infezzjoni. filgrastim ratiopharm huwa indikat għall-kura ta 'newtropenja persistenti (anc ta' inqas minn jew ugwali għal 1. 0 x 109 / l) f'pazjenti b'infezzjoni avvanzata ta 'l-hiv, sabiex jitnaqqas ir-riskju ta' infezzjonijiet batteriċi meta għażliet oħra biex tiġi amministrata n-newtropenija mhumiex xierqa.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren, amlodipine, hydrochlorothiazide - pressjoni għolja - sistema kardjovaskulari - rasitrio huwa indikat għall-kura ta ' l-ipertensjoni essenzjali bħala terapija ta ' sostituzzjoni fil-pazjenti adulti l-pressjoni tad-demm tagħhom huwa kontrollat adegwatament dwar il-kombinazzjoni ta ' aliskiren, amlodipine u idrochlorothiazide mogħtija fl-istess ħin fl-istess doża livell bħal fl-għaqda.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

novartis europharm limited - fingolimod hydrochloride - sklerosi multipla - immunosoppressanti - gilenya huwa indikat bħala terapija li timmodifika l-marda waħda fl attiva ħafna sklerożi multipla li tirkadi u tbatti l-isklerożi multipla għal dawn il-gruppi ta 'pazjenti adulti u pazjenti pedjatriċi ta'bejn l-10 snin u akbar:pazjenti b'ħafna marda attiva minkejja sħiħa u adegwata-kors tal-kura b'mill-inqas waħda li timmodifika l-marda ta' terapija (per eċċezzjonijiet u l-informazzjoni dwar il-perjodu tat-tneħħija ara sezzjonijiet 4. 4 u 5. orpatients mal li qed tevolvi malajr severa sklerożi multipla li tirkadi u tbatti l-isklerożi multipla definita minn 2 jew iktar diżabilità attakki reċidivi fis-sena, u b'1 jew aktar gadolinium-tisħiħ tal-leżjonijiet fuq il-moħħ ta 'l-mri jew żieda sinifikanti fil-t2 tal-leżjonijiet tat-tagħbija kif meta mqabbel ma ' qabel riċenti ta ' l-mri.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

zoetis belgium sa - dibotermin alfa - proteini morfogenetiċi għall-għadam - klieb - aġent osteoindużiv għall-użu fit-trattament ta 'ksur tal-għadam fit-tul bħala addizzjoni għal kura kirurġika standard bl-użu ta' tnaqqis fil-fratturi miftuħ fil-klieb.