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Category: 3.1 Bronchodilators

Name SMC ID No Manufacturer Status Sub. Type
 
aclidinium bromide (Eklira Genuair) 810/12 Almirall Ltd Accepted Full submission
aclidinium/formoterol fumarate dihydrate (Duaklir Genuair) 1034/15 Almirall Ltd Accepted Full submission
Tiotropium bromide (Spiriva®) 19/02 Boehringer Ingelheim Ltd Accepted Full submission
tiotropium (Spiriva-Respimat) 411/07 Boehringer Ingelheim Ltd Restricted Abbreviated Submission
olodaterol 2.5 microgram solution for inhalation (Striverdi® Respimat®) 974/14 Boehringer Ingelheim Ltd Not Recommended Full submission
olodaterol respimat (Striverdi Respimat) 974/14 Boehringer Ingelheim Ltd Accepted Resubmission
tiotropium, 2.5 microgram, solution for inhalation (Spiriva® Respimat®) 1028/15 Boehringer Ingelheim Ltd Accepted Full submission
tiotropium/olodaterol (Spiolto Respimat) 1099/15 Boehringer Ingelheim Ltd Accepted Abbreviated Submission
human alpha-1 proteinase inhibitor (Respreeza) 1157/16 CSL Behring Not Recommended Full submission
salmeterol 25 mcg inhaler (Serevent Evohaler) 292/06 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
salmeterol fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler) 450/08 GlaxoSmithKline UK Ltd Not Recommended Full submission
salmeterol xinafoate fluticasone propionate combination inhaler (Seretide) 450/08 GlaxoSmithKline UK Ltd Not Recommended Resubmission
fluticasone furoate/vilanterol (Relvar Ellipta) 953/14 GlaxoSmithKline UK Ltd Restricted Full submission
umeclidinium/vilanterol (Anoro®) 978/14 GlaxoSmithKline UK Ltd Not Recommended Full submission
umeclidinium / vilanterol (Anoro) 978/14 GlaxoSmithKline UK Ltd Accepted Resubmission
Fluticasone, salmeterol (Seretide Accuhaler®) 82/03 GlaxoSmithKline UK Ltd Accepted Full submission
salbutamol sulphate (Salbulin MDPI Novoliser) 504/08 Meda Pharmaceuticals Ltd Accepted Abbreviated Submission
fluticasone/formoterol (Flutiform) 736/11 Napp Pharmaceuticals Ltd Accepted Abbreviated Submission
glycopyrronium (Seebri Breezhaler) 829/12 Novartis Pharmaceuticals UK Ltd Accepted Full submission
indacaterol maleate, glycopyrronium bromide (Ultibro Breezhaler) 922/13 Novartis Pharmaceuticals UK Ltd Accepted Abbreviated Submission
formoterol 12 micrograms metered dose inhaler (Easyhaler) 375/07 Ranbaxy (UK) Ltd Accepted Abbreviated Submission
formoterol 12 micrograms metered dose inhaler (Atimos Modulite®) 239/06 Trinity-Chiesi Pharmaceuticals Ltd Accepted Abbreviated Submission
formoterol 12 mcg metered dose inhaler (Atimos Modulite) 349/07 Trinity-Chiesi Pharmaceuticals Ltd Accepted Abbreviated Submission

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