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SMC ID Date Medicine Submission Type Indication
SMC2178 10/06/2019 fluticasone/formoterol (Flutiform) Abbreviated For the licence extension of low strength flutiform (50/5 µg) in children aged 5 to <12 years. This fixed-dose combination of fluticasone propionate and formoterol fumarate (flutiform inhaler) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate: o For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β2 agonist. Or o For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist. flutiform 50 microgram/5 microgram inhaler is indicated in adults, adolescents and children aged 5 years and above.
SMC2016 11/06/2018 fluticasone/formoterol (flutiform k-haler) Abbreviated Indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate: • For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β2 agonist. • For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist. • flutiform k-haler) is indicated in adults and adolescents aged 12 years and above.
1303/18 12/02/2018 fluticasone furoate / umeclidinium / vilanterol (Trelegy Ellipta) Abbreviated Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist.
921/13 13/10/2014 azelastine hydrochloride + fluticasone propionate (Dymista) Abbreviated for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient.
966/14 09/06/2014 fluticasone furoate / vilanterol (Relvar Ellipta®) Full For the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate in patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists.
953/14 07/04/2014 fluticasone furoate/vilanterol (Relvar Ellipta) Full Symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.
736/11 08/10/2012 fluticasone/formoterol (Flutiform) Abbreviated for the regular treatment of asthma where the use of a combination product [an inhaled corticosteroid (ICS) and a long-acting β2 agonist (LABA)] is appropriate: for patients not adequately controlled on ICS and ‘as required' inhaled short-acting β2 / for patients already adequately controlled on both an ICS and a LABA.
544/09 14/04/2009 fluticasone furoate (Avamys) Full Allergic rhinitis in adults adolescents (12 years+) and children (6 to 11 years)
450/08 12/01/2009 salmeterol xinafoate fluticasone propionate combination inhaler (Seretide) Resubmission Symptomatic treatment of patients with chronic obstructive pulmonary disease (COPD)
450/08 10/03/2008 salmeterol fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler) Full For the symptomatic treatment of patients with chronic obstructive pulmonary disease (COPD)
108/04 12/07/2004 Seretide 50 Evohaler (Salmeterol xinafoate 25mcg/fluticasone propionate 50mcg) Abbreviated Asthma
82/03 08/12/2003 Fluticasone, salmeterol (Seretide Accuhaler®) Full Severe chronic obstructive pulmonary disease

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