Natalizumab Elan Pharma Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

natalizumab elan pharma

elan pharma international ltd. - natalizumab - marda ta 'crohn - immunostimulanti, - it-trattament ta attiva minn moderata sa gravi marda ta 'crohn għat-tnaqqis ta' sinjali u sintomi, u l-induzzjoni u l-manteniment ta ' rispons u remissjoni, fl-pazjenti li ma kellhomx rispons minkejja sħiħ u adegwat matul it-terapija b'kortikosterojde u l-immunosuppressant; jew li huma intolleranti għal, jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn.

Celdoxome pegylated liposomal Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

celdoxome pegylated liposomal

yes pharmaceutical development services gmbh - doxorubicin hydrochloride - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - aġenti antineoplastiċi - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Cabometyx Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

cabometyx

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - aġenti antineoplastiċi - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Anagrelide Mylan Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

anagrelide mylan

mylan pharmaceuticals limited - anagrelide hydrochloride - tromboċitemja, essenzjali - aġenti antineoplastiċi - anagrelide huwa indikat għat-tnaqqis tal-għadd għoli tal-plejtlets f'mill-riskju tromboċitemja essenzjali (et) tal-pazjenti li jkunu intolleranti għall it-terapija attwali tagħhom jew li l-għadd għoli tal-plejtlets tagħhom ma jitnaqqasx għal-livell aċċettabbli bit-terapija attwali tagħhom. an at-risk patientan at-risk essential thrombocythaemia patient is defined by one or more of the following features:>60 years of age ora platelet count >1,000 x 10⁹/l ora history of thrombo-haemorrhagic events.

Circadin Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

circadin

rad neurim pharmaceuticals eec sarl - melatonin - sleep inizjattiva u maintenance disorders - psikolettiċi - circadin huwa indikat bħala monoterapija għat-trattament għal żmien qasir ta 'nuqqas ta' rqad primarju kkaratterizzat minn kwalità fqira ta 'rqad f'pazjenti li għandhom 55 sena jew aktar.

Clopidogrel TAD Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

clopidogrel tad

tad pharma gmbh - clopidogrel (as hydrochloride) - peripheral vascular diseases; stroke; myocardial infarction - aġenti antitrombotiċi - clopidogrel is indicated in adults for the prevention of atherothrombotic events in: , patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

Yervoy Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

yervoy

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - aġenti antineoplastiċi - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 u 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.

Tysabri Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

tysabri

biogen netherlands b.v. - natalizumab - sklerosi multipla - immunosuppressanti selettivi - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (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.

Livtencity Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

livtencity

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.

Teriflunomide Mylan Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

teriflunomide mylan

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).