Unjoni Ewropea - Malti - EMA (European Medicines Agency)

era consulting gmbh - pegfilgrastim - newtropenja - immunostimulanti, , l-fatturi li jistimulaw kolonji - tnaqqis fit-tul tal-neutropenia u l-inċidenza tal-marda bid-deni neutropenia fil-pazjenti adulti ttrattati ċitotossiċi chemotherapy għall-malignancy (bl-eċċezzjoni ta ' kronika myeloid lewċemja u myelodysplastic sindromi).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - treosulfan - trapjant ta 'ċelloli staminali ematopojetiċi - aġenti antineoplastiċi - treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (allohsct) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

betapharm arzneimittel gmbh - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - aġenti antineoplastiċi - azacitidine betapharm huwa indikat għall-kura ta 'pazjenti adulti li mhumiex eliġibbli għat-trapjanti ta'ċelloli staminali ematopojetiċi (hsct) bil -: intermedji-2 u ta' riskju sindromi majelodisplastiċi (mds) skond l-international pronostiċi scoring system (ipss),lewkimja majelomonoċitika kronika (cmml) b'10 % sa 29 % tal-mudullun tal-blasts mingħajr disturbi majeloproliferattivi,lewkimja majelojde akuta (aml) b'20 % sa 30 % blasts u multi-lineage-displażija, skond l-organizzazzjoni dinjija tas-saħħa (who) il-klassifikazzjoni,l-aml b ' > 30 % tal-mudullun tal-blasts skond il-klassifikazzjoni tal-who.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - aġenti antineoplastiċi - azacitidine qbil huwa indikat għall-kura ta 'pazjenti adulti li mhumiex eliġibbli għat-trapjanti ta'ċelloli staminali ematopojetiċi (hsct) bil -: - intermedja-2 u ta' riskju sindromi majelodisplastiċi (mds) skond l-international pronostiċi scoring system (ipss),- lewkimja majelomonoċitika kronika (cmml) b'10-29 % tal-mudullun tal-blasts mingħajr majeloproliferattivi-disturb, il - lewċemija mjelojde akuta (aml) b'20-30 % blasts u multi-lineage-displażija, skond l-organizzazzjoni dinjija tas-saħħa (who) il-klassifikazzjoni, l - aml b ' >30% tal-mudullun tal-blasts skond il-klassifikazzjoni tal-who.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - aġenti antineoplastiċi - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosoppressanti - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - upadacitinib - artrite, rewmatika - immunosoppressanti - rheumatoid arthritisrinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (dmards). rinvoq may be used as monotherapy or in combination with methotrexate. psoriatic arthritisrinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more dmards. rinvoq may be used as monotherapy or in combination with methotrexate. axial spondyloarthritisnon-radiographic axial spondyloarthritis (nr-axspa)rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri), who have responded inadequately to nonsteroidal anti-inflammatory drugs (nsaids). ankylosing spondylitis (as, radiographic axial spondyloarthritis)rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. atopic dermatitisrinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. ulcerative colitisrinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.  crohn’s diseaserinvoq is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - eltrombopag - purpura, tromboċitopenika, idjopatika - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 u 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 u 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international nv - bortezomib - majloma multipla - aġenti antineoplastiċi - velcade bħala monotherapy jew f'kombinazzjoni ma ' pegylated liposomal doxorubicin jew dexamethasone huwa indikat għall-kura tal-pazjenti adulti bil-myeloma multipla progressiva li rċevew terapija mill-inqas 1 minn qabel u li jkunu diġà għaddew minn jew huma mhux tajjeb għal haematopoietic taċ-ċelloli staminali trapjant. velcade flimkien ma 'melphalan u prednisone huwa indikat għall-kura ta' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal doża għolja ta 'kimoterapija ma' trapjant b ' ċelluli staminali ematopojetiċi. velcade flimkien ma 'dexamethasone, jew ma' dexamethasone u thalidomide, huwa indikat għall-kura ta 'induzzjoni ta' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li huma eliġibbli għal doża għolja ta 'kimoterapija bi trapjant b' ċelluli staminali ematopojetiċi. velcade flimkien ma 'rituximab, cyclophosphamide, doxorubicin u prednisone huwa indikat għall-kura ta' pazjenti adulti li ma kienux ikkurati qabel f'forma ta'tubu taċ-ċelluli tal-limfoma li mhumiex tajbin għal trapjant b ' ċelluli staminali ematopojetiċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - bortezomib - majloma multipla - aġenti antineoplastiċi - bortezomib bħala monoterapija jew flimkien ma 'liposomal doxorubicin jew dexamethasone hu indikat għall-kura ta' pazjenti adulti b'progressiva majeloma multipla li rċevew mill-anqas terapija 1 minn qabel u li diġà għaddew jew li mhumiex tajbin għal trapjant b ' ċelluli staminali ematopojetiċi. bortezomib flimkien ma 'melphalan u prednisone huwa indikat għall-kura ta' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal doża għolja ta 'kimoterapija bi trapjant b' ċelluli staminali ematopojetiċi. bortezomib flimkien ma 'dexamethasone, jew ma' dexamethasone u thalidomide, huwa indikat għall-kura ta 'induzzjoni ta' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li huma eliġibbli għal doża għolja ta 'kimoterapija bi trapjant b' ċelluli staminali ematopojetiċi. bortezomib flimkien ma 'rituximab, cyclophosphamide, doxorubicin u prednisone huwa indikat għall-kura ta' pazjenti adulti li ma kienux ikkurati qabel f'forma ta'tubu taċ-ċelluli tal-limfoma li mhumiex tajbin għal trapjant b ' ċelluli staminali ematopojetiċi.