Eiropas Savienība - maltiešu - 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.

Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

accord healthcare s.l.u. - apixaban - venous thromboembolism; stroke; arthroplasty - aġenti antitrombotiċi - prevention of venous thromboembolic events (vte) in adult patients who have undergone elective hip or knee replacement surgery. il-prevenzjoni ta 'puplesija u emboliżmu sistematiku f'pazjenti adulti b'nuqqas valvulari fibrillazzjoni atrijali (nvaf), ma'wieħed jew aktar fatturi ta' riskju, bħal qabel puplesija jew attakk iskemiku temporanju (tia); età ≥ 75-il sena; pressjoni għolja; d-dijabete mellitus; insuffiċjenza tal-qalb sintomatika (nyha klassi ≥ ii). trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti (ara sezzjoni 4. 4 għall-emodinamikament instabbli pe pazjenti). prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (nvaf), with one or more risk factors, such as prior stroke or transient ischaemic attack (tia); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (nyha class ≥ ii). trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti (ara sezzjoni 4. 4 għall-emodinamikament instabbli pe pazjenti).

Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

accord healthcare s.l.u. - dabigatran etexilate mesilate - venous thromboembolism; arthroplasty, replacement - aġenti antitrombotiċi - prevention of venous thromboembolic events.

Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - majloma multipla - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 u 5. 1)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.

Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 u 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

pierre fabre medicament - tabelecleucel - lymphoproliferative disorders - ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory epstein-barr virus positive post-transplant lymphoproliferative disease (ebv+ ptld) who have received at least one prior therapy. for solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - sklerosi multipla - immunosuppressanti selettivi - 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).

Eiropas Savienība - maltiešu - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Eiropas Savienība - maltiešu - 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).