Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, metformin hydroklorid - diabetes mellitus, typ 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 och 5. 1 för tillgänglig data på olika kombinationer).

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - guanfacinhydroklorid - attention deficit disorder med hyperaktivitet - antiadrenergic agents, centrally acting, antihypertensives, - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. intuniv måste användas som en del av en omfattande adhd-behandling-program, som vanligtvis inklusive psykologiska, pedagogiska och sociala åtgärder.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin - diabetes mellitus, typ 2 - läkemedel som används vid diabetes - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 och 5.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - läkemedel som används vid diabetes - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 och 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil hydroklorid - kolorektala neoplasmer - antineoplastiska medel - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

astrazeneca ab - olaparib - Äggstockar neoplasmer - antineoplastiska medel - Äggstockscancer cancerlynparza är indicerat som monoterapi för:underhåll behandling av vuxna patienter med avancerad (figo stadierna iii och iv) brca1/2-muterad (könsceller och/eller somatisk) hög-kvalitet epitelial äggstockscancer, äggledare eller primär peritoneal cancer, som är ett svar på (helt eller delvis) efter genomförandet av den första linjens platinum-baserad 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 och 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. patienter bör ha tidigare behandlats med en anthracycline och en taxane i (neo)adjuvant eller metastaserande inställningen om patienter som inte var lämpliga för dessa behandlingar (se avsnitt 5. patienter med hormon receptor (hr)-positiv bröstcancer bör också ha kommit på eller efter föregående endokrin terapi, eller anses vara olämpliga för endokrin 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.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

amgen europe b.v. - romiplostim - purpura, trombocytopenisk, idiopatisk - hemostatika - adults:nplate is indicated for the treatment of primary immune thrombocytopenia  (itp) in adult patients who are refractory to other treatments (e. kortikosteroider, immunoglobuliner). paediatrics:nplate is indicated for the treatment of chronic primary immune thrombocytopenia (itp) in paediatric patients one year of age and older who are refractory to other treatments (e. kortikosteroider, immunoglobuliner).

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

teva b.v. - ribavirin - hepatit c, kronisk - antivirala medel för systemisk användning - ribavirin teva pharma b. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis c (chc) in adults (see sections 4. 2, 4. 4 och 5. ribavirin teva pharma b. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis c (chc) for paediatric patients (children 3 years of age and older and adolescents) notpreviously treated and without liver decompensation (see sections 4. 2, 4. 4 och 5.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - lamivudin - hepatit b, kronisk - antivirala medel för systemisk användning - zeffix is indicated for the treatment of chronic hepatitis b in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. inledande av lamivudin för behandling bör ses endast när användningen av en alternativ antivirala medel med en högre genetisk barriär är inte tillgänglig eller är lämpligt,, dekompenserad leversjukdom i kombination med andra agent utan kors-resistens mot lamivudin.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv-infektioner - antivirala medel för systemisk användning - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.