Unión Europea - inglés - EMA (European Medicines Agency)

glaxo group ltd. - fluticasone furoate - rhinitis, allergic, perennial; rhinitis, allergic, seasonal - nasal preparations - adults, adolescents (12 years and over) and children (6 - 11 years). alisade is indicated for the treatment of the symptoms of allergic rhinitis.

Unión Europea - inglés - EMA (European Medicines Agency)

glaxo group ltd - retapamulin - impetigo; staphylococcal skin infections - antibiotics and chemotherapeutics for dermatological use - short term treatment of the following superficial skin infections: , impetigo;, infected small lacerations, abrasions or sutured wounds. , see sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of staphylococcus aureus. consideration should be given to official guidance on the appropriate use of antibacterial agents.,

Unión Europea - inglés - EMA (European Medicines Agency)

mylan pharmaceuticals limited - amlodipine besilate, valsartan - hypertension - agents acting on the renin-angiotensin system - treatment of essential hypertension.amlodipine/valsartan mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Unión Europea - inglés - EMA (European Medicines Agency)

amgen europe b.v. - darbepoetin alfa - anemia; cancer; kidney failure, chronic - other antianemic preparations - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adults and paediatric patients.treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Unión Europea - inglés - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen*: a/california/7/2009 (h1n1)v like strain (x-179a)*propagated in eggs. - influenza, human; immunization; disease outbreaks - influenza vaccines - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance

Unión Europea - inglés - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole mylan pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole mylan pharma is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.aripiprazole mylan pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.

Unión Europea - inglés - EMA (European Medicines Agency)

mylan ire healthcare limited - fondaparinux sodium - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - antithrombotic agents - 1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injectionprevention of venous thromboembolic events (vte) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery.prevention of vte in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery.prevention of vte in adult medical patients who are judged to be at high risk for vte and who are immobilised due to acute illness such as cardiac insufficiency and / or acute respiratory disorders, and / or acute infectious or inflammatory disease.treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.2.5-mg/0.5-ml solution for injectiontreatment of unstable angina or non-st-segment-elevation myocardial infarction (ua/nstemi) in adult patients for whom urgent (< 120 mins) invasive management (pci) is not indicated.infarction (stemi) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.5-mg/0.4-ml, 7.5-mg/0.6-ml and 10-mg/0.8-ml solution for injectiontreatment of adults with acute deep-vein thrombosis (dvt) and treatment of acute pulmonary embolism (pe), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Unión Europea - inglés - EMA (European Medicines Agency)

mylan pharmaceuticals limited - atazanavir (as sulfate) - hiv infections - antivirals for systemic use - atazanavir mylan, co-administered with low dose ritonavir, is indicated for the treatment of hiv 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 pi mutations). there are very limited data available from children aged 6 to less than 18 years.the choice of atazanavir mylan in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

Unión Europea - inglés - EMA (European Medicines Agency)

smithkline beecham ltd - rosiglitazone, glimepiride - diabetes mellitus, type 2 - drugs used in diabetes - avaglim is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.

Unión Europea - inglés - EMA (European Medicines Agency)

smithkline beecham plc - rosiglitazone, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - avandamet is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients:who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea (see section 4.4).