Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astellas pharma europe b.v. - roxadustat - anemia; kidney failure, chronic - preparazzjonijiet antianemiċi - evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (ckd).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirali għal użu sistemiku - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 u 5. tecovirimat siga should be used in accordance with official recommendations.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

eigerbio europe limited - lonafarnib - progeria; laminopathies - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of hutchinson-gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous lmna mutation with progerin-like protein accumulation or a homozygous or compound heterozygous zmpste24 mutation.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - immunosoppressanti - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - lewkimja, mjeloġenika, kronika, bcr-abl pożittiva - aġenti antineoplastiċi - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - infezzjonijiet taċ-ċitomegalovirus - antivirali għal użu sistemiku - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu adattat ta ' aġenti antivirali.

Unjoni Ewropea - Malti - 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).

Unjoni Ewropea - Malti - 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).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - aġenti antineoplastiċi - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

eli lilly nederland b.v. - dulaglutide - diabetes mellitus, tip 2 - drugs used in diabetes, blood glucose lowering drugs, excl. insulins - trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. għall-riżultati tal-istudju fir-rigward tal-kombinazzjonijiet, l-effetti fuq il-kontroll gliċemiku u episodji kardjovaskulari, u l-popolazzjonijiet studjati, ara sezzjonijiet 4. 4, 4. 5 u 5.