Idefirix Kesatuan Eropah - Malta - EMA (European Medicines Agency)

idefirix

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - immunosoppressanti - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Blincyto Kesatuan Eropah - Malta - EMA (European Medicines Agency)

blincyto

amgen europe b.v. - blinatumomab - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Locatim (previously Serinucoli) Kesatuan Eropah - Malta - EMA (European Medicines Agency)

locatim (previously serinucoli)

biokema anstalt - lakoserum ikkonċentrat tal-bovini li fih immunoglobulini speċifiċi g kontra e. coli f5 (k99) adhesin - immunoloġiċi għall-bovidae - għoġġiela, tarbija tat-twelid ta 'inqas minn 12-il siegħa - tnaqqis ta 'mortalità kkawżat minn enterotossikosi assoċjata ma' e. coli f5 (k99) adhesin matul l-ewwel jiem tal-ħajja bħala suppliment għall-kolostru mid-diga.

Nplate Kesatuan Eropah - Malta - EMA (European Medicines Agency)

nplate

amgen europe b.v. - romiplostim - purpura, tromboċitopenika, idjopatika - sustanzi kontra l-emorraġija - adults:nplate is indicated for the treatment of primary immune thrombocytopenia  (itp) in adult patients who are refractory to other treatments (e. kortikosterojdi, immunoglobulini). paediatrics:nplate is indicated for the treatment of chronic primary immune thrombocytopenia (itp) in paediatric patients one year of age and older who are refractory to other treatments (e. kortikosterojdi, immunoglobulini).

Nyxthracis (previously Obiltoxaximab SFL) Kesatuan Eropah - Malta - EMA (European Medicines Agency)

nyxthracis (previously obiltoxaximab sfl)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - sera immuni u immunoglobulini, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

Tecvayli Kesatuan Eropah - Malta - EMA (European Medicines Agency)

tecvayli

janssen-cilag international n.v. - teclistamab - majloma multipla - aġenti antineoplastiċi - tecvayli is indicated as monotherapy 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.

Vepacel Kesatuan Eropah - Malta - EMA (European Medicines Agency)

vepacel

ology bioservices ireland ltd - virus ta 'l-influwenza (virjon sħiħ, mhux attivat), li fih antiġen ta': a / vietnam / 1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaċċini ta 'l-influwenza - immunizzazzjoni attiva kontra s-sottotip h5n1 tal-virus ta 'l-influwenza a.. din l-indikazzjoni hija bbażata fuq dejta ta 'immunoġeniċità minn individwi mill-età ta' 6-il xahar wara amministrazzjoni ta 'żewġ dożi ta' vaċċin ippreparati bl-sottotip h5n1 razez. vepacel għandu jintuża skont il-gwida uffiċjali.

Pandemic Influenza Vaccine H5N1 Baxter AG Kesatuan Eropah - Malta - EMA (European Medicines Agency)

pandemic influenza vaccine h5n1 baxter ag

resilience biomanufacturing ireland limited - influwenza avjana (kollu virion, mhux attivati) li jkun fih anti $ enu ta: a/vjetnam/1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaċċini - profilassi tal-influwenza f'sitwazzjoni pandemika ddikjarata uffiċjalment. il-vaċċin kontra l-influwenza pandemika għandu jintuża skond il-gwida uffiċjali.

Humira Kesatuan Eropah - Malta - EMA (European Medicines Agency)

humira

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - immunosoppressanti - jekk jogħġbok irreferi għad-dokument ta 'informazzjoni dwar il-prodott.

Briumvi Kesatuan Eropah - Malta - EMA (European Medicines Agency)

briumvi

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosoppressanti - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.