European Union - English - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - fluticasone furoate, vilanterol - pulmonary disease, chronic obstructive - adrenergics and other drugs for obstructive airway diseases - asthma indication:relvar ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists.patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist.copd indication:relvar ellipta is indicated for the symptomatic treatment of adults with copd with a fev1

European Union - English - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - fluticasone furoate, vilanterol trifenatate - asthma - adrenergics and other drugs for obstructive airway diseases - asthma indicationrevinty ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists.copd indicationrevinty ellipta is indicated for the symptomatic treatment of adults with copd with a fev1

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - vokanamet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated doses of metformin alonein patients on their maximally tolerated doses of metformin along with other glucose lowering medicinal products including insulin, when these do not provide adequate glycaemic control.in patients already being treated with the combination of canagliflozin and metformin as separate tabletsfor study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

European Union - English - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - oritavancin (diphosphate) - soft tissue infections; skin diseases, bacterial - antibacterials for systemic use, - tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and paediatric patients aged 3 months and older (see sections 4.2, 4.4 and 5.1).consideration should be given to official guidance on the appropriate use of antibacterial agents.

European Union - English - EMA (European Medicines Agency)

berlin-chemie ag - edoxaban tosilate - stroke; venous thromboembolism - antithrombotic agents - prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (nvaf) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (tia).treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults.

European Union - English - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - atosiban (as acetate) - premature birth - other gynecologicals - tractotile is indicated to delay imminent pre-term birth in pregnant adult women with:regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes;a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50%;a gestational age from 24 until 33 completed weeks;a normal foetal heart rate.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a. menarini farmaceutica internazionale srl - febuxostat - tablet - 120mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a. menarini farmaceutica internazionale srl - febuxostat - tablet - 80mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

napp pharmaceuticals ltd - canagliflozin hemihydrate - tablet - 300mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

napp pharmaceuticals ltd - canagliflozin hemihydrate - tablet - 100mg