Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Europäische Union - Deutsch - EMA (European Medicines Agency)

efavirenz/emtricitabine/tenofovir disoproxil krka

krka, d.d., novo mesto - efavirenz, emtricitabin, tenofovir disoproxil succinat - hiv-infektionen - antivirale mittel zur systemischen anwendung - efavirenz / emtricitabin / tenofovir disoproxil krka ist eine kombination aus efavirenz, emtricitabin und tenofovir disoproxil in fester dosierung. es ist indiziert für die behandlung der infektion mit dem humanen immundefizienz-virus-1 (hiv-1) im alter von 18 jahren und älter mit virologischen unterdrückung zu hiv-1-rna < 50 kopien/ml auf ihre aktuelle antiretrovirale kombinationstherapie für mehr als drei monate. patienten müssen nicht virologischem versagen vorherige antiretrovirale therapie erlebt haben und nicht zu virusstämme mutationen verleihen erhebliche widerstände gegen eines der drei komponenten in efavirenz hegte haben bekannt sein / emtricitabin/tenofovir disoproxil krka vor beginn ihrer ersten antiretrovirale therapie. die demonstration der vorteil von efavirenz/emtricitabin/tenofovir disoproxil ist in erster linie basiert auf 48-wochen-daten aus einer klinischen studie, in der patienten mit stabiler virologic unterdrückung auf eine kombination antiretrovirale therapie geändert efavirenz/emtricitabin/tenofovir disoproxil. derzeit liegen keine daten aus klinischen studien mit efavirenz, emtricitabin/tenofovir disoproxil behandlung-naiven oder bei stark vorbehandelten patienten. keine daten sind verfügbar zur unterstützung der kombination von efavirenz/emtricitabin/tenofovir disoproxil und andere antiretrovirale wirkstoffe.

Phelinun Europäische Union - Deutsch - EMA (European Medicines Agency)

phelinun

adienne s.r.l. s.u. - melphalan hydrochloride - multiple myeloma; hodgkin disease; lymphoma, non-hodgkin; precursor cell lymphoblastic leukemia-lymphoma; leukemia, myeloid, acute; neuroblastoma; ovarian neoplasms; hematopoietic stem cell transplantation - antineoplastische mittel - high-dose of phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (hodgkin, non-hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma. phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (ric) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-hsct) in malignant haematological diseases in adults. phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:myeloablative conditioning (mac) treatment in case of malignant haematological diseasesric treatment in case of non-malignant haematological diseases.

Lenalidomide Mylan Europäische Union - Deutsch - EMA (European Medicines Agency)

lenalidomide mylan

mylan ireland limited - lenalidomid - multiples myelom - immunsuppressiva - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).

Lenalidomide Krka d.d. Europäische Union - Deutsch - EMA (European Medicines Agency)

lenalidomide krka d.d.

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - immunsuppressiva - multiple myelomalenalidomide krka d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) ist indiziert für die behandlung erwachsener patienten mit zuvor unbehandeltem multiplen myelom, die nicht die voraussetzungen für eine transplantation. lenalidomide krka d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. follicular lymphomalenalidomide krka d. in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Sitagliptin SUN Europäische Union - Deutsch - EMA (European Medicines Agency)

sitagliptin sun

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - diabetes mellitus, typ 2 - drogen bei diabetes verwendet - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Celdoxome pegylated liposomal Europäische Union - Deutsch - EMA (European Medicines Agency)

celdoxome pegylated liposomal

yes pharmaceutical development services gmbh - doxorubicinhydrochlorid - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - antineoplastische mittel - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Adcetris Europäische Union - Deutsch - EMA (European Medicines Agency)

adcetris

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - antineoplastische mittel - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd). adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct). adcetris ist indiziert für die behandlung von erwachsenen patienten mit rezidiviertem oder refraktärem cd30+ hodgkin-lymphom (hl):nach asct, orfollowing mindestens zwei vorherigen therapien, wenn asct oder multi-agent-chemotherapie ist keine therapieoption. systemische anaplastische große zelle lymphomaadcetris in kombination mit cyclophosphamid, doxorubicin und prednison (kwk) ist indiziert für erwachsene patienten mit zuvor unbehandeltem, systemische anaplastische großen zell-lymphom (salcl). adcetris ist indiziert für die behandlung von erwachsenen patienten mit rezidiviertem oder refraktärem salcl. kutane t-zell-lymphomaadcetris ist indiziert für die behandlung von erwachsenen patienten mit cd30+ kutanen t-zell-lymphom (ctcl) nach mindestens 1 vorherige systemische therapie.

Elonva Europäische Union - Deutsch - EMA (European Medicines Agency)

elonva

n.v. organon - corifollitropin alfa - reproductive techniques, assisted; ovulation induction; investigative techniques - sexualhormone und modulatoren des genital-system, - controlled ovarian stimulation (cos) in combination with a gnrh antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (art) program. elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human chorionic gonadotropin (hcg).

Epivir Europäische Union - Deutsch - EMA (European Medicines Agency)

epivir

viiv healthcare bv - lamivudin - hiv-infektionen - antivirale mittel zur systemischen anwendung - epivir ist indiziert als teil einer antiretroviralen kombinationstherapie zur behandlung von mit menschlichem immunschwächevirus (hiv) infizierten erwachsenen und kindern.

Iscover Europäische Union - Deutsch - EMA (European Medicines Agency)

iscover

sanofi winthrop industrie - clopidogrel - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - antithrombotische mittel - sekundäre prävention von atherothrombotischen eventsclopidogrel ist indiziert bei:erwachsenen patienten mit herzinfarkt (wenige tage bis weniger als 35 tage), mit ischämischen schlaganfall (7 tage bis weniger als 6 monate) oder etablierte periphere arterielle krankheit. erwachsenen patienten mit akutem koronarsyndrom:nicht-st-segment elevation acute coronary syndrome (instabile angina pectoris oder non-q-wave-myokardinfarkt), einschließlich patienten, die sich einer stent-implantation folgenden perkutanen koronarintervention in kombination mit acetylsalicylsäure (asa). st segment elevation acute myocardial infarction, in combination with asa in patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic stroke (is)clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. prävention von atherothrombotischen und thromboembolischer ereignisse bei vorhofflimmern fibrillationin erwachsenen patienten mit vorhofflimmern, die mindestens einen risikofaktor für vaskuläre ereignisse, sind nicht geeignet für die behandlung mit vitamin-k-antagonisten (vka) und die haben ein niedriges blutungsrisiko, clopidogrel ist indiziert in kombination mit ass für die prävention von atherothrombotischen und thromboembolischer ereignisse, einschließlich schlaganfall.