Evrópusambandið - íslenska - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; psoriasis; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; crohn disease; arthritis, juvenile rheumatoid - Ónæmisbælandi lyf - rheumatoid arthritisyuflyma 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. yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab hefur verið sýnt fram á að draga úr framvindu sameiginlega skaða sem mæla með x-ray og til að bæta líkamlega virka, þegar gefið ásamt stendur. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisyuflyma 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). yuflyma 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 hefur ekki verið rannsakað í sjúklinga á aldrinum minna en 2 ár. enthesitis-related arthritisyuflyma 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)yuflyma 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 asyuflyma 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 non-steroidal anti-inflammatory drugs (nsaids). psoriatic arthritisyuflyma 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 hefur verið sýnt fram á að draga úr framvindu af útlimum sameiginlega skaða sem mæla með x-ray í sjúklinga með fjölliða samhverfu flokkar sjúkdómsins (sjá kafla 5. 1) og til að bæta líkamlega virka. psoriasisyuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasisyuflyma 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)yuflyma 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 (see sections 5. 1 5. crohn’s diseaseyuflyma 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 diseaseyuflyma 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 colitisyuflyma 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 colitisyuflyma 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. uveitisyuflyma 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 uveitisyuflyma 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - brjóstakrabbamein - Æxlishemjandi lyf - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Evrópusambandið - íslenska - 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 - Æxlishemjandi lyf - 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. sjá nánar í kafla 5 til að fá nánari upplýsingar varðandi húðþéttni vaxtarþáttar viðtaka 2 (her2). 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. nánari upplýsingar um her2 stöðu, sjá kafla 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.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

alvogen pharma trading europe eood - vinorelbinum tvítartrat - mjúkt hylki - 30 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

hameln pharma gmbh - dexamethasonum natríumfosfat - stungulyf, lausn - 4 mg/ml

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

sandoz a/s - teriflunomidum inn - filmuhúðuð tafla - 14 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

laboratorios normon s.a. - anidulafunginum inn - stofn fyrir innrennslisþykkni, lausn - 100 mg

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh - bevacizumab - carcinoma, non-small-cell lung; breast neoplasms; ovarian neoplasms; colorectal neoplasms; carcinoma, renal cell - Æxlishemjandi lyf - bevacizumab samhliða krabbameinslyfjameðferð með flúorópýrímídíni er ætlað til meðferðar hjá fullorðnum sjúklingum með krabbamein í meinvörpum í ristli eða endaþarmi. bevacizumab ásamt paclitaxel er ætlað fyrir fyrsta lína meðferð fullorðinn sjúklinga með brjóstakrabbamein. nánari upplýsingar er eins og að mönnum api vöxt þáttur viðtaka 2 (her2) stöðu. bevacizumab ásamt capecitabine er ætlað fyrir fyrsta lína meðferð fullorðinn sjúklinga með brjóstakrabbamein í hvern meðferð með öðrum lyfjameðferð valkosti þar á meðal taxani eða antracýklín er ekki talið viðeigandi. sjúklingar sem hafa fengið inntöku skatta- og antracýklínhvarfa við viðbótarmeðferð innan 12 mánaða skal útiloka meðferð með avastin ásamt capecítabíni. nánari upplýsingar er eins og að her2 stöðu. bevacizumab, auk þess að platínu-byggt lyfjameðferð, er ætlað fyrir fyrsta lína meðferð fullorðinn sjúklinga með unresectable háþróaður, sjúklingum eða endurtekin ekki lítið klefi lungnakrabbamein annað en aðallega æxli klefi vefjasýni. bevacizumab, ásamt erlotinib, er ætlað fyrir fyrsta lína meðferð fullorðinn sjúklinga með unresectable háþróaður, sjúklingum eða endurtekin ekki æxli ekki lítið klefi lungnakrabbamein með api vöxt Þáttur viðtaka (egfr) virkja stökkbreytingar. bevacizumab ásamt fylgjast alfa-2a er ætlað fyrir fyrsta lína meðferð fullorðinn sjúklinga með langt og/eða sjúklingum skert klefi krabbamein. bevacizumab, ásamt carboplatín og paclitaxel er ætlað fyrir framan-línu meðferð fullorðinn sjúklinga með langt (international samtök Ættfræði og fæðingu (figo) stigum iii b, iii c og iv) þekju blöðrur, eggjaleiðara, eða aðal kviðarholi krabbamein. bevacizumab, ásamt carboplatín og gemcitabin, er ætlað fyrir meðferð fullorðinn sjúklinga með fyrsta endurkomu platínu-viðkvæm þekju blöðrur, eggjaleiðara eða aðal kviðarholi krabbamein sem hafa ekki fengið áður en meðferð með bevacizumab eða öðrum vegf hemlar eða vegf viðtaka–miða lyfjum. bevacizumab ásamt paclitaxel, tópótecan, eða mjög liposomal doxórúbicíns er ætlað fyrir meðferð fullorðinn sjúklinga með platínu-þola endurtekin þekju blöðrur, eggjaleiðara, eða aðal kviðarholi krabbamein sem fékk ekki meira en tvö áður en lyfjameðferð meðferð og sem hafa ekki fengið áður en meðferð með bevacizumab eða öðrum vegf hemlar eða vegf viðtaka–miða lyfjum. bevacizumab, ásamt paclitaxel og cisplatíni eða að öðrum kosti, paclitaxel og tópótecan í sjúklingar sem getur ekki fengið platínu meðferð, er ætlað fyrir meðferð fullorðinn sjúklinga með viðvarandi, endurtekin, eða sjúklingum krabbamein í legháls.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - sveppalyf fyrir almenn nota - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

acino ag - klópídógrel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - blóðþurrðandi lyf - 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, non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa), st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy, patients suffering from acute coronary syndrome. , ,.