União Europeia - maltês - EMA (European Medicines Agency)

bayer ag - riociguat - pressjoni għolja, pulmonari - antihypertensives għall-ipertensjoni arterjali pulmonari - chronic thromboembolic pulmonary hypertension (cteph)adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah)adultsadempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. l-effikaċja ġiet murija fil-pah popolazzjoni inklużi l-etjoloġiji ta idjopatika jew li tintiret-pah jew pah assoċċjata ma'mard tal-connective tissue. paediatricsadempas is indicated for the treatment of pah in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with who functional class (fc) ii to iii in combination with endothelin receptor antagonists.

União Europeia - maltês - EMA (European Medicines Agency)

the medicines company uk ltd - bivalirudin - sindromu koronarju akut - aġenti antitrombotiċi - angiox huwa indikat bħala antikoagulant f'pazjenti adulti li għaddejjin minn intervent koronarju perkutanju (pci), inklużi pazjenti b'infezzjoni mijokardijaka ta 'elevazzjoni tas-segment st (stemi) li għaddejjin minn pci primarju. angiox huwa wkoll indikat għall-kura ta ' pazjenti adulti b'anġina instabbli / mhux-st segment tal-elevazzjoni tal-infart mijokardijaku (ua / nstemi) ippjanati għal intervent urġenti jew bikri. angiox għandu jingħata ma ' aspirina u clopidogrel.

União Europeia - maltês - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - emoglobinurja, paroxysmal - immunosuppressanti selettivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

União Europeia - maltês - EMA (European Medicines Agency)

instituto grifols, s.a. - fibrinoġen uman, trombina umana - hemostasi, kirurġiċi - sustanzi kontra l-emorraġija - trattament ta ' sostenn fl-adulti, fejn tekniċi kirurġiċi standard mhumiex biżżejjed:għat-titjib tal-haemostasisas appoġġ għas-sutura fil-kirurġija vaskulari.

União Europeia - maltês - EMA (European Medicines Agency)

canyon pharmaceuticals ltd. - desirudin - trombożi venuża - aġenti antitrombotiċi - prevenzjoni ta 'trombożi fil-vini fil-fond f'pazjenti li għaddejjin minn kirurġija ta' sostituzzjoni tal-ġenb jew tal-irkoppa elettiva.

União Europeia - maltês - EMA (European Medicines Agency)

glaxo group ltd. - fondaparinux sodium - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - aġenti antitrombotiċi - 5 mg / 0. 3 ml u 2. 5 mg / 0. 5 ml, soluzzjoni għall-injezzjoni:, il-prevenzjoni ta ' każi trombo-emboliċi venużi (vte) f'pazjenti għaddejjin minn kirurġija ortopedika maġġuri tar-riġlejn bħal fratturi fil-ġenb, kirurġija maġġuri fl-irkoppa jew tal-ġenbejn operazzjoni tas-sostituzzjoni. , il-prevenzjoni ta 'każi trombo-emboliċi venużi (vte) f'pazjenti għaddejjin minn kirurġija addominali li huma meqjusa f'riskju għoli ta 'kumplikazzjonijiet ta' trombo-emboliżmu, bħal pazjenti li jgħaddu minn kirurġija għall-kanċer (ara sezzjoni 5. , il-prevenzjoni ta 'każi trombo-emboliċi venużi (vte) f' pazjenti mediċi li huma meqjusa f'riskju għoli ta 'vte u li huma immobili minħabba mard akut bħal insuffiċienza kardijaka u/jew mard respiratorju akut, u/jew mard akut infettiv jew ta' infjammazzjoni. , , 2. 5 mg / 0. 5 ml, soluzzjoni għall-injezzjoni:, it-trattament ta 'anġina mhux stabbli jew mhux tas-segment st' infart mijokardijaku b'elevazzjoni (ua/nstemi) fil-pazjenti li għalihom urġenti (< 120 minuta) invasif (pci) mhuwiex indikat (ara sezzjonijiet 4. 4 u 5. , it-trattament tal-elevazzjoni tas-segment st 'infart mijokardijaku (stemi) f'pazjenti li huma ttrattati b'trombolitiċi jew li fil-bidu qegħdin jirċievu l-ebda forma oħra ta' riperfużjoni-terapija. , , 5 mg/0. 4 ml, 7. 5 mg / 0. 6 ml u 10 mg / 0. 8 ml soluzzjoni għall-injezzjoni:, it-trattament ta 'trombożi f' vina fonda (dvt) u t-trattament ta ' emboliżmu pulmonari (pe), ħlief fil-ħruġ emodinamikament instabbli, jew pazjenti li għandhom bżonn tromboliżi jew embolektomija.

União Europeia - maltês - EMA (European Medicines Agency)

eli lilly nederland b.v. - drotrecogin alfa (attivat) - sepsis; multiple organ failure - aġenti antitrombotiċi - xigris huwa indikat għat-trattament ta 'pazjenti adulti li għandhom sepsis severi b'fattil ta' organu multiplu meta miżjud ma 'l-aħjar kura standard. l-użu ta 'xigris għandu jiġi kkunsidrat prinċipalment f'sitwazzjonijiet fejn it-terapija tista' tinbeda fi żmien 24 siegħa wara l-bidu ta 'falliment ta' organi (għal aktar informazzjoni ara t-taqsima 5.

União Europeia - maltês - EMA (European Medicines Agency)

bpl bioproducts laboratory gmbh - - fattur tal-koagulazzjoni x - fattur x defiċjenza - vitamin k and other hemostatics, antihemorrhagics, coagulation factor x - coagadex huwa indikat għat-trattament u profilassi ta 'episodji ta' fsada u għal ġestjoni perioperattiva f'pazjenti b'defiċjenza ereditarja ta 'fattur x. coagadex huwa indikat fil-gruppi kollha tal-età.

União Europeia - maltês - EMA (European Medicines Agency)

corza medical gmbh - fibrinoġen uman, trombina umana - hemostasi, kirurġiċi - sustanzi kontra l-emorraġija - tachosil is indicated in adults and children from 1 month of age for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. tachosil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.

União Europeia - maltês - EMA (European Medicines Agency)

mylan ire healthcare limited - fondaparinux sodium - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - aġenti antitrombotiċi - 5-mg / 0. 3-ml u 2. 5-mg / 0. 5-ml solution for injectionprevention of venous thromboembolic events (vte) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. il-prevenzjoni ta 'vte fl-adulti li għaddejjin minn kirurġija addominali li huma meqjusa f'riskju għoli ta 'kumplikazzjonijiet ta' trombo-emboliżmu, bħal pazjenti li jgħaddu minn kirurġija ta ' kanċer. il-prevenzjoni ta 'vte fl-adulti' pazjenti mediċi li huma meqjusa f'riskju għoli ta 'vte u li huma immobili minħabba mard akut bħal insuffiċienza kardijaka u / jew mard respiratorju akut, u / jew mard akut infettiv jew ta' infjammazzjoni. it-trattament ta'adulti bl-sintomatiku akut spontanju superfiċjali-trombożi tal-vina tar-riġlejn mingħajr konkomitanti fil-fond tal-trombożi tal-vina. 5-mg / 0. 5-ml solution for injectiontreatment of unstable angina or non-st-segment-elevation myocardial infarction (ua/nstemi) in adult patients for whom urgent (< 120 mins) invasive management (pci) is not indicated. infart tal-qalb (stemi) f'pazjenti adulti li huma ttrattati b'trombolitiċi jew li fil-bidu qegħdin jirċievu l-ebda forma oħra ta ' riperfużjoni-terapija. 5-mg / 0. 4 ml, 7. 5-mg / 0. 6-ml u 10 mg/0. 8-ml solution for injectiontreatment of adults with acute deep-vein thrombosis (dvt) and treatment of acute pulmonary embolism (pe), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.