Europäische Union - Schwedisch - EMA (European Medicines Agency)

mylan pharmaceuticals limited - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - antitrombotiska medel - clopidogrel/acetylsalicylsyra mylan är indicerat för sekundär prevention av atherothrombotic händelser hos vuxna patienter som redan tar både klopidogrel och acetylsalicylsyra (asa). clopidogrel/acetylsalicylsyra mylan är en fast dos kombination läkemedel för fortsatt behandling i:icke-st-segment höjd akuta koronara syndrom (instabil angina eller icke-q-våg hjärtinfarkt), inklusive patienter som genomgår en stent placering efter perkutan koronar interventionst segment höjd akut hjärtinfarkt i medicinskt behandlade patienter berättigade till trombolysbehandling.

Europäische Union - Schwedisch - EMA (European Medicines Agency)

mylan ireland limited - arsenik svaveltrioxid - leukemi, promyelocytisk, akut - antineoplastiska medel - arsenik svaveltrioxid mylan är indicerat för induktion av remission, och konsolidering hos vuxna patienter med:- som nyligen fått diagnosen låg till intermediär risk akut promyeloisk leukemi (apl) (vita blodkroppar, ≤ 10 x 103/µl) i kombination med alla trans retinoinsyra (atra)- Återfall/refraktär akut promyeloisk leukemi (apl) (tidigare behandling ska ha inkluderat en retinoid och kemoterapi)kännetecknas av närvaron av t(15;17) translokation och/eller förekomst av promyeloisk leukemi/retinoinsyra receptor alpha (pml/rar-alfa) - gen. svarsfrekvensen av andra akut myeloisk leukemi subtyper arsenik antimontrioxid har inte beenexamined.

Europäische Union - Schwedisch - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberkulos, multidrug-resistent - medel mot mykobakterier - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). hänsyn bör tas till officiella riktlinjer för lämplig användning av antibakteriella medel.

Europäische Union - Schwedisch - 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.

Europäische Union - Schwedisch - EMA (European Medicines Agency)

mylan ire healthcare 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 - treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Europäische Union - Schwedisch - 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.

Europäische Union - Schwedisch - EMA (European Medicines Agency)

mylan ireland limited - dimetylfumarat - multipel skleros, skovvis förlöpande - immunsuppressiva - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Europäische Union - Schwedisch - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multipel skleros, skovvis förlöpande - immunsuppressiva - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Europäische Union - Schwedisch - EMA (European Medicines Agency)

viatris limited - pirfenidon - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - immunsuppressiva - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Europäische Union - Schwedisch - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - läkemedel som används vid diabetes - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 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. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.