Euroopan unioni - malta - EMA (European Medicines Agency)

sandoz gmbh - adalimumab - spondylitis, ankylosing; hidradenitis suppurativa; psoriasis; arthritis, juvenile rheumatoid; uveitis - immunosoppressanti - rewmatika arthritishefiya flimkien ma ' methotrexate, huwa indikat għall -: - trattament ta moderata sa severa, artrite rewmatika attiva f'pazjenti adulti, meta r-rispons li jimmodifikaw il-marda anti-rewmatiċi-mediċini inkluż methotrexate, ma jkunx adegwat. il-kura ta attiva u progressiva severa, artrite rewmatika fl-adulti li ma kienux ittrattati qabel b'methotrexate. hefiya jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat. adalimumab ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. idjopatika ġuvenili arthritispolyarticular-artrite idjopatika ġuvenili hefiya flimkien ma 'methotrexate huwa indikat għall-kura tal-attivi-artrite idjopatika ġuvenili poliartikulari, f'pazjenti mill-età ta' 2 snin li kellhom rispons inadegwat għal wieħed jew aktar li jimmodifikaw il-marda anti-rewmatiċi-mediċini (dmards). hefiya jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta titkompla l-kura b'methotrexate ma tkunx tajba (għall-effikaċja fil-monoterapija ara sezzjoni 5. adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. artrite assoċjata ma'entesite hefiya huwa indikat għall-kura tal-attivi-artrite assoċjata ma'entesite fil-pazjenti, l-età ta ' 6 snin u akbar, li kellhom rispons mhux adegwat għal, jew li huma intolleranti għal, terapija konvenzjonali (ara sezzjoni 5. assjali spondyloarthritisankylosing ankilosanti (as) hefiya huwa indikat għall-kura ta ' adulti li jbatu minn ankylosing spondylitis attiva li kellhom rispons mhux adekwat għat-terapija. assjali aksjali mingħajr evidenza radjografika ta 'kif hefiya huwa indikat għall-kura ta' adulti li jbatu minn assjali aksjali mingħajr evidenza radjografika ta 'kif iżda bil-għan sinjali ta' infjammazzjoni minn crp għoli u / jew ta ' l-mri, li kellhom rispons mhux adegwat għal, jew li huma intolleranti għal mediċini anti-infjammatorji. psorjatika arthritishefiya huwa indikat għall-kura tas-sustanza attiva u progressiva artrite psorjatika fl-adulti meta r-rispons għall-preċedenti li jimmodifikaw il-marda anti-rewmatiċi terapija bil-mediċina kienet inadegwata. adalimumab ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi periferali kif imkejjel permezz ta' x-ray f'pazjenti b'sottotipi poliartikulari simmetriċi tal-marda (ara sezzjoni 5. 1) u li jtejjeb il-funzjoni fiżika. psoriasishefiya huwa indikat għall-kura moderata għal severa ta ' psorjasi tal-plakka kronika f'pazjenti adulti li huma kandidati għat-terapija sistemika. pedjatrika tal-plakka psoriasishefiya huwa indikat għall-kura ta kroniku sever tal-psorjasi tal-plakka fit-tfal u fl-adolexxenti mill-età ta ' 4 snin li kellhom rispons inadegwat għal, jew huma xierqa għall-kandidati għal terapija topika u fototerapiji. pedjatrika tal-plakka psoriasishefiya huwa indikat għall-kura ta kroniku sever tal-psorjasi tal-plakka fit-tfal u fl-adolexxenti mill-età ta ' 4 snin li kellhom rispons inadegwat għal, jew huma xierqa għall-kandidati għal terapija topika u fototerapiji. hidradenitis suppurativa (sa)hefiya huwa indikat għall-kura ta attiva minn moderata sa severa hidradenitis suppurativa (akne inversa) fl-adulti u addoloxxenti minn 12 il-sena b'rispons mhux adekwat għat-sistemiċi sa terapija. crohn diseasehefiya huwa indikat għall-kura ta attiva minn moderata sa gravi marda ta ' crohn f'pazjenti adulti li ma kellhomx rispons minkejja sħiħ u adegwat matul it-terapija b'xi corticosteroid u / jew immunosoppressanti; jew li huma intolleranti għal, jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn. pedjatriċi crohn diseasehefiya huwa indikat għall-kura ta attiva minn moderata sa gravi marda ta 'crohn f'pazjenti pedjatriċi (mill-età ta' 6 snin) li kellhom rispons mhux adekwat għat-terapija konvenzjonali, inkluż primarja nutrizzjoni-terapija u xi corticosteroid u / jew immunomodulatur, jew li ma jifilħux jew għandhom kontra-indikazzjonijiet għal dawn it-terapiji. paediatric ulcerative colitishefiya is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.  ulcerative colitis hefiya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.  uveitis hefiya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.  paediatric uveitis hefiya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Euroopan unioni - malta - EMA (European Medicines Agency)

sandoz gmbh - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; arthritis, juvenile rheumatoid; crohn disease; skin diseases, papulosquamous - immunosoppressanti - rheumatoid arthritishyrimoz in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hyrimoz jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat. adalimumab ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. juvenile idiopathic arthritis- polyarticular juvenile idiopathic arthritishyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). hyrimoz jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat. adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. - enthesitis-related arthritishyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. axial spondyloarthritis- ankylosing spondylitis (as)hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. - axial spondyloarthritis without radiographic evidence of ashyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and / or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. psoriatic arthritishyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. adalimumab ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi periferali kif imkejjel permezz ta' x-ray f'pazjenti b'sottotipi poliartikulari simmetriċi tal-marda, u li jtejjeb il-funzjoni fiżika. psoriasishyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy. crohn’s diseasehyrimoz is indicated for treatment of moderately to severely active crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseasehyrimoz is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.  paediatric ulcerative colitishyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. ulcerative colitishyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitishyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Euroopan unioni - malta - EMA (European Medicines Agency)

viiv healthcare b.v. - dolutegravir tas-sodju, rilpivirina hydrochloride - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - juluca huwa indikat għall-kura tal-vajrus tal-immunodefiċjenza umana tat-tip 1 (hiv-1) f'adulti li huma viroloġikament-mrażżna (hiv-1 rna.

Euroopan unioni - malta - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. 1 of the smpc. aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. 1 of the smpc. aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. 1 of the smpc). aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. 1 of the smpc). aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5. 1 of the smpc).

Euroopan unioni - malta - EMA (European Medicines Agency)

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.

Euroopan unioni - malta - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. onbevzi in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with onbevzi in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. onbevzi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. onbevzi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. onbevzi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. onbevzi, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. onbevzi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Euroopan unioni - malta - EMA (European Medicines Agency)

mabxience research sl - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. alymsys in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with alymsys in combination with capecitabine. alymsys, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. alymsys, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. alymsys, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. alymsys, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. alymsys, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. alymsys, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Euroopan unioni - malta - EMA (European Medicines Agency)

stada arzneimittel ag - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. oyavas in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. oyavas in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with oyavas in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. oyavas, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. oyavas, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. oyavas, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. oyavas, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. oyavas, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. oyavas, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Euroopan unioni - malta - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Euroopan unioni - malta - EMA (European Medicines Agency)

stada arzneimittel ag - adalimumab - arthritis, psoriatic; arthritis, juvenile rheumatoid; arthritis, rheumatoid; colitis, ulcerative; crohn disease; hidradenitis suppurativa; psoriasis; spondylitis, ankylosing; uveitis - immunosoppressanti - rheumatoid arthritishukyndra in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritishukyndra in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more dmard. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. enthesitis-related arthritishukyndra is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritisankylosing spondylitis (as)hukyndra is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of ashukyndra is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). psoriatic arthritishukyndra is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. adalimumab ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi periferali kif imkejjel permezz ta' x-ray f'pazjenti b'sottotipi poliartikulari simmetriċi tal-marda (ara sezzjoni 5. 1) u li jtejjeb il-funzjoni fiżika. psoriasishukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishukyndra is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)hukyndra is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 u 5. crohn’s diseasehukyndra is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseasehukyndra is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitishukyndra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitishukyndra is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishukyndra is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitishukyndra is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.