You are here:
Name SMC ID No Manufacturer Status Sub. Type
 
salbutamol sulphate (Salbulin MDPI Novoliser) 504/08 Meda Pharmaceuticals Ltd Accepted Abbreviated Submission
icatibant (Firazyr) 476/08 Shire Pharmaceuticals Accepted Resubmission
budesonide (Pulmicort) 536/09 AstraZeneca UK Ltd Accepted Abbreviated Submission
indacaterol (Onbrez Breezhaler) 619/10 Novartis Pharmaceuticals UK Ltd Accepted Full submission
adrenaline tartrate 150/300 micrograms solution for injection in pre-filled pen (Jext) 687/11 ALK-Abello Ltd Accepted Abbreviated Submission
fluticasone/formoterol (Flutiform) 736/11 Napp Pharmaceuticals Ltd Accepted Abbreviated Submission
caffeine Citrate 20mg/ml solution for infusion and oral solution (Peyona) 814/12 Chiesi Limited Accepted Full submission
aclidinium bromide (Eklira Genuair) 810/12 Almirall Ltd Accepted Full submission
glycopyrronium (Seebri Breezhaler) 829/12 Novartis Pharmaceuticals UK Ltd Accepted Full submission
fluticasone furoate / vilanterol (Relvar Ellipta®) 966/14 GlaxoSmithKline UK Ltd Accepted Full submission
beclometasone dipropionate / formoterol fumarate dihydrate (Fostair) 976/14 Chiesi Limited Accepted Abbreviated Submission
umeclidinium / vilanterol (Anoro) 978/14 GlaxoSmithKline UK Ltd Accepted Resubmission
olodaterol respimat (Striverdi Respimat) 974/14 Boehringer Ingelheim Ltd Accepted Resubmission
umeclidinium (Incruse) 1004/14 GlaxoSmithKline UK Ltd Accepted Full submission
indacaterol maleate, glycopyrronium bromide (Ultibro Breezhaler) 922/13 Novartis Pharmaceuticals UK Ltd Accepted Abbreviated Submission
aclidinium/formoterol fumarate dihydrate (Duaklir Genuair) 1034/15 Almirall Ltd Accepted Full submission
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
Budesonide inhaler 100mcg, 200mcg, 400mcg (Easyhaler® Budesonide) 241/06 Ranbaxy (UK) Ltd Accepted Abbreviated Submission
Budesonide/eformoterol (Symbicort) 97/04 AstraZeneca UK Ltd Accepted Full submission
formoterol 12 micrograms metered dose inhaler (Atimos Modulite®) 239/06 Trinity-Chiesi Pharmaceuticals Ltd Accepted Abbreviated Submission
montelukast (Singulair) 111/04 MSD Accepted Abbreviated Submission
Seretide 50 Evohaler (Salmeterol xinafoate 25mcg/fluticasone propionate 50mcg) 108/04 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
Tiotropium bromide (Spiriva®) 19/02 Boehringer Ingelheim Ltd Accepted Full submission
beclometasone dipropionate (Clenil Modulite) 177/05 Trinity-Chiesi Pharmaceuticals Ltd Accepted Abbreviated Submission
salmeterol 25 mcg inhaler (Serevent Evohaler) 292/06 GlaxoSmithKline UK Ltd Accepted Abbreviated Submission
budesonide 200mcg (Novolizer®) inhaler 306/06 Meda Pharmaceuticals Ltd Accepted Abbreviated Submission
budesonide/formoterol 100/6, 200/6 turbohaler (Symbicort SMART) 362/07 AstraZeneca UK Ltd Accepted Full submission
formoterol 12 micrograms metered dose inhaler (Easyhaler) 375/07 Ranbaxy (UK) Ltd Accepted Abbreviated Submission
formoterol 12 mcg metered dose inhaler (Atimos Modulite) 349/07 Trinity-Chiesi Pharmaceuticals Ltd Accepted Abbreviated Submission
ciclesonide 80mcg , 160mcg inhaler (Alvesco) 412/07 Altana Pharma Ltd Accepted Abbreviated Submission
beclometasone 100mcg, formoterol 6mcg metered dose inhaler (Fostair®) 373/07 Trinity-Chiesi Pharmaceuticals Ltd Accepted Abbreviated Submission
budesonide-formoterol (Symbicort SMART) 1244/17 AstraZeneca UK Ltd Accepted Abbreviated Submission
tiotropium (Spiriva Respimat) 411/07 Boehringer Ingelheim Ltd Accepted Abbreviated Submission
Fluticasone, salmeterol (Seretide Accuhaler®) 82/03 GlaxoSmithKline UK Ltd Accepted Full submission
icatibant (Firazyr) 476/08 Jerini AG Not Recommended Full submission
roflumilast (Daxas) 635/10 Nycomed UK Ltd Not Recommended Full submission
conestat (Ruconest) 745/11 Not Recommended Non submission
caffeine citrate (Peyona) 814/12 Chiesi Pharmaceuticals/Trinity Pharmaceuticals Not Recommended Non submission
ivacaftor (Kalydeco) 827/12 Vertex Pharmaceuticals Ltd Not Recommended Full submission
ivacaftor (Kalydeco) 827/12 Vertex Pharmaceuticals Ltd Not Recommended Resubmission
inhaled mannitol (Bronchitol) 837/13 Pharmaxis Pharmaceuticals Ltd Not Recommended Full submission
timothy grass pollen allergen (GRAZAX) 868/13 ALK-Abello Ltd Not Recommended Non submission
ivacaftor (Kalydeco) 1134/16 Vertex Pharmaceuticals Ltd Not Recommended Full submission
lumacaftor-ivacaftor (Orkambi) 1136/16 Vertex Pharmaceuticals Ltd Not Recommended Full submission
human alpha-1 proteinase inhibitor (Respreeza) 1157/16 CSL Behring Not Recommended Full submission
budesonide-formoterol (Symbicort) 1198/16 AstraZeneca UK Ltd Not Recommended Non submission
ivacaftor (Kalydeco) 1193/16 Vertex Pharmaceuticals Ltd Not Recommended Full submission
umeclidinium/vilanterol (Anoro®) 978/14 GlaxoSmithKline UK Ltd Not Recommended Full submission
olodaterol 2.5 microgram solution for inhalation (Striverdi® Respimat®) 974/14 Boehringer Ingelheim Ltd Not Recommended Full submission
standardised allergen extract of grass pollen from Timothy (Phleum pratense) 75,000 SQ-T per oral lyophilisate 367/07 ALK-Abello Ltd Not Recommended Full submission
standardised allergen extract of grass pollen from Timothy (Phleum pratense) 75,000 SQ-T per oral lyophilisate 367/07 ALK-Abello Ltd Not Recommended Resubmission
erdosteine 300mg capsules (Erdotin) 415/07 Edmond Pharma Sr.I/Galen Ltd Not Recommended Full 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
bilastine (Ilaxten®) 730/11 A Menarini Pharmaceuticals UK Ltd Not Recommended Non submission
roflumilast (Daxas) 635/10 AstraZeneca UK Ltd Not Recommended Resubmission
reslizumab (Cinqaero) 1233/17 Teva UK Limited Not Recommended Resubmission
mepolizumab (Nucala) 1149/16 GlaxoSmithKline UK Ltd Restricted Full submission
fluticasone furoate/vilanterol (Relvar Ellipta) 953/14 GlaxoSmithKline UK Ltd Restricted Full submission
omalizumab (Xolair) 1017/14 Novartis Pharmaceuticals UK Ltd Restricted Full submission
pirfenidone (Esbriet®) 835/13 Intermune UK Ltd Restricted Resubmission
Ciclesonide (Alvesco®) 249/06 Altana Pharma Ltd Restricted Full submission
Ciclesonide (Alvesco®) 184/05 Altana Pharma Ltd Restricted Full submission
Mometasone furoate (Asmanex Twisthaler®) 79/03 Schering-Plough Ltd Restricted Full submission
montelukast (Singulair) 185/05 MSD Restricted Full submission
Moxifloxacin (Avelox®) 69/03 Bayer plc/Bayer Schering Pharma Restricted Full submission
montelukast (Singulair paediatric) 383/07 MSD Restricted Full submission
tiotropium (Spiriva-Respimat) 411/07 Boehringer Ingelheim Ltd Restricted Abbreviated Submission
beclometasone dipropionate anhydrous/formoterol fumarate dihydrate/glycopyrronium bromide (Trimbow) 1274/17 Chiesi Limited Restricted Abbreviated Submission
fluticasone furoate / umeclidinium / vilanterol (Trelegy Ellipta) 1303/18 GlaxoSmithKline UK Ltd Restricted Abbreviated Submission
omalizumab (Xolair) 611/10 Novartis Pharmaceuticals UK Ltd Superseded Abbreviated Submission
omalizumab 75mg, 150mg solution for injection (Xolair) 708/11 Novartis Pharmaceuticals UK Ltd Superseded Abbreviated Submission
Omalizumab 150mg powder and solvent for injection (Xolair) 259/06 Novartis Pharmaceuticals UK Ltd Superseded Full submission
omalizumab 150mg powder and solvent for injection (Xolair) 259/06 Novartis Pharmaceuticals UK Ltd Superseded Resubmission
omalizumab 150mg powder and solvent for injection (Xolair) 259/06 Novartis Pharmaceuticals UK Ltd Superseded Resubmission
rupatadine (Rupafin) 612/10 GlaxoSmithKline UK Ltd Withdrawn Non submission

Back