Европейский союз - датский - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - docetaxel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - antineoplastiske midler - bryst cancerdocetaxel kabi i kombination med doxorubicin og cyclophosphamid er angivet for den adjuverende behandling af patienter med:betjenes node-positiv brystkræft;betjenes node-negativ brystkræft. for patienter med betjenes node-negativ brystkræft, adjuverende behandling bør begrænses til patienter, der er berettiget til at modtage kemoterapi i henhold til internationalt anerkendte kriterier for primære behandling af tidlig brystkræft. docetaxel kabi i kombination med doxorubicin er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft, der ikke tidligere har modtaget cytotoksisk behandling for denne tilstand. docetaxel kabi monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter svigt af cytotoksiske terapi. tidligere kemoterapi skulle have inkluderet et anthracyclin eller et alkyleringsmiddel. docetaxel kabi i kombination med trastuzumab er indiceret til behandling af patienter med metastatisk brystcancer, hvis tumorer overexpress her2, og som ikke tidligere har modtaget kemoterapi for metastatisk sygdom. docetaxel kabi i kombination med capecitabin, er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi. tidligere behandling skulle have inkluderet en antracyklin. non-small-cell lung cancerdocetaxel kabi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikke-small-cell lung cancer efter svigt af før kemoterapi. docetaxel kabi i kombination med cisplatin er indiceret til behandling af patienter med inoperabel lokalt fremskreden eller metastatisk ikke-small-cell lung cancer hos patienter, der ikke tidligere har modtaget kemoterapi for denne tilstand. prostate cancerdocetaxel kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer. docetaxel kabi i kombination med androgen-afsavn terapi (adt), med eller uden prednison eller prednisolon, er indiceret til behandling af patienter med metastatisk hormon-følsomme prostatakræft. gastrisk adenocarcinomadocetaxel kabi i kombination med cisplatin og 5-fluorouracil er indiceret til behandling af patienter med metastatisk gastrisk adenocarcinom, herunder adenocarcinoma af gastroøsofageal vejkryds, der ikke har modtaget forudgående kemoterapi for metastatisk sygdom. hoved og hals cancerdocetaxel kabi i kombination med cisplatin og 5-fluorouracil er indiceret til induktion behandling af patienter med lokalt fremskreden pladecellekræft i hoved og hals.

Европейский союз - датский - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. se afsnit 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Европейский союз - датский - EMA (European Medicines Agency)

astrazeneca ab - olaparib - Æggestokkene neoplasmer - antineoplastiske midler - Æggestokkene cancerlynparza er angivet som monoterapi til:vedligeholdelse behandling af voksne patienter med avanceret (figo faser iii og iv) brca1/2-muterede (germline og/eller somatiske) high-grade epitelial ovariecancer, æggeleder eller primær peritoneal cancer, der er i reaktion (hel eller delvis) efter afslutningen af første linje platin-baseret kemoterapi. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 og 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. patienter bør have, der tidligere er blevet behandlet med en antracyklin og en taxane i (neo)adjuvans eller metastatisk indstilling, medmindre patienter, der ikke var egnet til disse behandlinger (se afsnit 5. patienter med hormon receptor (hr)-positiv brystkræft bør også have udviklet sig på eller efter forudgående endokrine terapi, eller anses uegnet til at endokrine terapi. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Европейский союз - датский - EMA (European Medicines Agency)

roche registration gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell - antineoplastiske midler - mabthera er angivet i voksne til følgende indikationer:non‑hodgkin ' s lymfom (nhl)mabthera er indiceret til behandling af tidligere ubehandlede voksne patienter med stadium iii‑iv, follikulært lymfom i kombination med kemoterapi. mabthera vedligeholdelse terapi er indiceret til behandling af voksne follikulært lymfom patienter reagerer på induktion terapi. mabthera monoterapi er indiceret til behandling af voksne patienter med stadium iii‑iv, follikulært lymfom, der er chemoresistant eller er i deres andet eller efterfølgende tilbagefald efter kemoterapi. mabthera er indiceret til behandling af voksne patienter med cd20-positive diffuse store b-celle non‑hodgkin ' s lymfom i kombination med chop (cyclofosfamid, doxorubicin, vincristin, prednisolon) kemoterapi. mabthera i kombination med kemoterapi er indiceret til behandling af pædiatriske patienter (i alderen ≥ 6 måneder < 18 år) med tidligere ubehandlet fremskredent stadium cd20-positive diffuse store b-celle lymfom (dlbcl), burkitt lymfom (bl)/burkitt leukæmi (mature b-celle akut leukæmi) (bal) eller burkitt-som lymfom (bll). kronisk lymfatisk leukæmi (cll)mabthera i kombination med kemoterapi er indiceret til behandling af patienter med tidligere ubehandlet og recidiverende/refraktær cll. foreligger kun begrænsede oplysninger om effekt og sikkerhed for patienter, der tidligere er behandlet med monoklonale antistoffer, herunder mabthera eller patienter ildfaste materialer til tidligere mabthera plus kemoterapi. reumatoid arthritismabthera i kombination med methotrexat er indiceret til behandling af voksne patienter med svær aktiv leddegigt, der har haft et utilstrækkeligt respons eller intolerance over for andre sygdomsmodificerende anti‑reumatiske lægemidler (dmard), herunder en eller flere tumor nekrose faktor (tnf) - hæmmer behandlinger. mabthera har vist sig at reducere hastigheden af progressionen af ledskader, som målt ved hjælp af x‑ray, og til at forbedre den fysiske funktion, når det gives i kombination med methotrexat. granulomatosis med polyangiitis og mikroskopiske polyangiitismabthera, i kombination med glukokortikoider er indiceret til behandling af voksne patienter med svær, aktive granulomatosis med polyangiitis (wegeners) (gpa) og mikroskopisk polyangiitis (mpa). mabthera i kombination med glukokortikoider er indiceret til induktion af remission hos pædiatriske patienter (i alderen ≥ 2 < 18 år) med svær, aktive gpa (wegeners) og mpa. pemphigus vulgarismabthera er indiceret til behandling af patienter med moderat til svær pemphigus vulgaris (pv).

Европейский союз - датский - EMA (European Medicines Agency)

pfizer europe ma eeig - tigecycline - bacterial infections; skin diseases, bacterial; soft tissue infections - antibakterielle midler til systemisk brug, - tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: , complicated skin and soft tissue infections (cssti), excluding diabetic foot infections, complicated intra-abdominal infections (ciai) , tygacil should be used only in situations where other alternative antibiotics are not suitable. det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler.. hensigtsmæssig brug af antibakterielle midler..

Европейский союз - датский - EMA (European Medicines Agency)

pfizer europe ma eeig - tafamidis - amyloidose - andre narkotika stoffer - vyndaqel er indiceret til behandling af transthyretinamyloidose hos voksne patienter med fase 1-symptomatisk polyneuropati for at forsinke perifer neurologisk nedsat funktion.

Европейский союз - датский - EMA (European Medicines Agency)

astellas pharma europe b.v. - enzalutamide - prostatiske neoplasmer - endokrine terapi - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Европейский союз - датский - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis; microscopic polyangiitis; pemphigus - antineoplastiske midler - rixathon is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)rixathon is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. rixathon maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. rixathon monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. rixathon is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. rixathon in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). kronisk lymfatisk leukæmi (cll)rixathon i kombination med kemoterapi er indiceret til behandling af patienter med tidligere ubehandlet og recidiverende/refraktær kronisk lymfatisk leukæmi. foreligger kun begrænsede oplysninger om effekt og sikkerhed for patienter, der tidligere er behandlet med monoklonale antistoffer, herunder rituximab eller patienter ildfaste materialer til tidligere rituximab plus kemoterapi. se afsnit 5. 1 for yderligere information. reumatoid arthritisrixathon i kombination med methotrexat er indiceret til behandling af voksne patienter med svær aktiv leddegigt, der har haft et utilstrækkeligt respons eller intolerance over for andre sygdomsmodificerende anti-reumatiske lægemidler (dmard), herunder en eller flere tumor nekrose faktor (tnf) - hæmmer behandlinger. rituximab har vist sig at reducere hastigheden af progressionen af ledskader, som målt ved hjælp af x-ray, og til at forbedre den fysiske funktion, når det gives i kombination med methotrexat. granulomatosis with polyangiitis and microscopic polyangiitisrixathon, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). rixathon, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisrixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Европейский союз - датский - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - antineoplastiske midler - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. foreligger kun begrænsede oplysninger om effekt og sikkerhed for patienter, der tidligere er behandlet med monoklonale antistoffer, herunder rituximab eller patienter ildfaste materialer til tidligere rituximab plus kemoterapi. se afsnit 5. 1 for yderligere information. rheumatoid arthritisriximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies. rituximab har vist sig at reducere hastigheden af progressionen af ledskader, som målt ved hjælp af x-ray, og til at forbedre den fysiske funktion, når det gives i kombination med methotrexat. granulomatosis with polyangiitis and microscopic polyangiitisriximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Дания - датский - Lægemiddelstyrelsen (Danish Medicines Agency)

teva b.v. - acetylsalicylsyre - tabletter - 150 mg