New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - fluticasone propionate 500ug (micronised);  ;  ;  ; salmeterol xinafoate 72.5ug equivalent to 50 µg of salmeterol base;  ;  ;   - powder for inhalation - 500µg/50µg - active: fluticasone propionate 500ug (micronised)       salmeterol xinafoate 72.5ug equivalent to 50 µg of salmeterol base       excipient: lactose monohydrate - seretide is indicated for the regular treatment of asthma (reversible obstructive airways disease), where use of a combination product (bronchodilator and inhaled corticosteroid) is appropriate. this may include: patients on effective maintenance doses of both long-acting beta-agonists and inhaled corticosteroids using separate therapy. patients who are not adequately controlled on current inhaled corticosteroid therapy. patients who are not adequately controlled on 'as needed' short-acting beta-agonistsm as an alternative to initiation of maintenance therapy with moderate or high doses of inhaled corticosteroids alone. seretide should not typically be used for the initial management of asthma, unless symptoms are severely uncontrolled, nor in patients whose asthma can be managed by occasional use of short-acting beta-2 agonists. seretide should not be used in the treatment of acute asthmatic symptoms.

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoire aguettant - atropine sulfate monohydrate - solution for injection in pre-filled syringe - 0.1 milligram(s)/millilitre - belladonna alkaloids, tertiary amines; atropine - belladonna alkaloids, tertiary amines - atropine sulfate aguettant 0.1 mg/ml, solution for injection in pre-filled syringe is indicated in adults and in paediatric population from birth, but with a body weight superior to 3 kg - as a pre-anaesthetic medication to prevent vagal reactions associated with tracheal intubation and surgical manipulation, - to limit the muscarinic effects of neostigmine, when given postsurgically to counteract non-depolarising muscle relaxants - treatment of hemodynamically compromising bradycardia and/ or atrioventricular block due to excessive vagal tone in emergency situation - cardiopulmonary resuscitation: to treat symptomatic bradycardia and av block - as antidote following overdosage or poisoning with acetylcholinesterase-inhibitors e.g. anticholinesterases, organophosphorus, carbamates and muscarinic mushrooms

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoire aguettant - phenylephrine hydrochloride - solution for injection in pre-filled syringe - 50 microgram(s)/millilitre - adrenergic and dopaminergic agents; phenylephrine - adrenergic and dopaminergic agent - treatment of hypotension during spinal, epidural or general anesthesia

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoires besins international - testosterone - gel - 16.2 milligram(s)/gram - 3-oxoandrosten (4) derivatives; testosterone - androgens. - testogel 16.2 mg/g is indicated in adults as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests

European Union - English - EMA (European Medicines Agency)

glaxosmithkline trading services limited - albiglutide - diabetes mellitus, type 2 - drugs used in diabetes - eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as:monotherapywhen diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance.add-on combination therapyin combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).

European Union - English - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - fluticasone furoate - rhinitis, allergic, seasonal; rhinitis, allergic, perennial - nasal preparations, corticosteroids - adults, adolescents (12 years and over) and children (6-11 years). avamys is indicated for the treatment of the symptoms of allergic rhinitis.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis b surface antigen - hepatitis b; immunization - vaccines - fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus inactivated, containing antigen equivalent to a/california/07/2009 (h1n1)-derived strain used nymc x-179a - influenza, human; immunization; disease outbreaks - influenza vaccines - prophylaxis of influenza caused by a (h1n1)v 2009 virus. pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (h1n1)v is considered necessary (see sections 4.4 and 4.8).pandemrix should be used in accordance with official guidance.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - a/indonesia/05/2005 (h5n1) like strain used (pr8-ibcdc-rg2) - influenza, human; immunization; disease outbreaks - vaccines - active immunisation against h5n1 subtype of influenza-a virus.this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared with h5n1 subtype strains.prepandrix should be used in accordance with official guidance.

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

glaxosmithkline uk ltd - hepatitis a virus inactivated; hepatitis b virus surface antigen - suspension for injection