Unió Europea - suec - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombotiska medel - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Unió Europea - suec - EMA (European Medicines Agency)

akcea therapeutics ireland limited - volanesorsen natrium - hyperlipoproteinemi typ i - andra lipidmodifierande medel - waylivra är indicerat som komplement till kosten hos vuxna patienter med genetiskt bekräftat familjär chylomicronemia syndrom (fcs) och hög risk för pankreatit, i vilken respons till kost och triglycerider sänka behandling har varit otillräckligt.

Unió Europea - suec - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, typ 2 - läkemedel som används vid diabetes - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. sitagliptin/metformin hydrochloride mylan is indicated in combination with a sulphonylurea (i. - , trippel kombinationsterapi) som ett komplement till kost och motion hos patienter bristfälligt kontrollerad på deras maximal tolererad dos av metformin och en sulphonylurea. sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist. sitagliptin/metformin hydrochloride mylan is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Unió Europea - suec - 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 - antineoplastiska medel - 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. för vidare information om human epidermal growth factor receptor 2 (her2) status, se avsnitt 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. för ytterligare information om her2-status, se avsnitt 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.

Unió Europea - suec - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - fluticasone furoate, vilanterol - pulmonell sjukdom, kronisk obstruktiv - adrenergika och andra läkemedel för obstruktiva luftvägssjukdomar - astma indikation:relvar ellipta anges i regelbunden behandling av astma hos vuxna och ungdomar i åldern 12 år och äldre, där man använder en kombination produkt (långverkande beta2-agonist och inhalerad kortikosteroid) är lämplig:för patienter som inte kontrolleras på ett adekvat sätt med inhalerade kortikosteroider och "som behövs" inhalerad kortverkande beta2-agonister. patienter som redan kontrolleras på ett adekvat sätt på både inhalerad kortikosteroid och långverkande beta2-agonist. kol indikation:relvar ellipta är indicerat för symtomatisk behandling av vuxna med kol med fev1.

Unió Europea - suec - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - fluticasone furoate, vilanterol trifenatate - astma - adrenergika och andra läkemedel för obstruktiva luftvägssjukdomar - astma indicationrevinty ellipta anges i regelbunden behandling av astma hos vuxna och ungdomar i åldern 12 år och äldre, där man använder en kombination produkt (långverkande beta2-agonist och inhalerad kortikosteroid) är lämplig:för patienter som inte kontrolleras på ett adekvat sätt med inhalerade kortikosteroider och "som behövs" inhalerad kortverkande beta2-agonister. kol indicationrevinty ellipta är indicerat för symtomatisk behandling av vuxna med kol med fev1.

Unió Europea - suec - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - eptifibatid - angina, unstable; myocardial infarction - antitrombotiska medel - integrilin är avsett för användning med acetylsalicylsyra och unfractionerat heparin. integrilin är indicerat för prevention av tidig hjärtinfarkt i patienter som kommer in med instabil angina eller icke-q-våg hjärtinfarkt med det senaste avsnittet av bröstsmärta som inträffar inom 24 timmar och med ekg-förändringar och / eller förhöjd hjärt-enzymer. patienter som är mest troligt att dra nytta av integrilin behandling är personer med hög risk att utveckla hjärtinfarkt inom de första 3-4 dagar efter uppkomsten av akut kärlkramp symtom som till exempel de som är benägna att genomgå en tidig perkutan transluminal koronarangioplastik (ptca).

Unió Europea - suec - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belimumab - lupus erythematosus, systemic - immunsuppressiva - benlysta är indicerat som tillägg på terapi hos patienter i åldern 5 år och äldre med aktiva, positiva autoantikroppar systemisk lupus erythematosus (sle) med en hög grad av sjukdomsaktivitet (e. positiv anti-dsdna och låg komplement) trots standardbehandling. benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

Unió Europea - suec - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastiska medel - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Unió Europea - suec - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cystisk fibros - andra andningsorganprodukter - orkambi tabletter är indicerat för behandling av cystisk fibros (cf) hos patienter i åldern 6 år och äldre och som är homozygot för den f508del mutation i cftr-genen. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.