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Name SMC ID No Manufacturer Status Sub. Type
 
riociguat (Adempas) 1001/14 Bayer plc/Bayer Schering Pharma Restricted Full submission
apixaban (Eliquis) 1029/15 Pfizer/Bristol Myers Squbb Accepted Full submission
riociguat (Adempas) 1056/15 Bayer plc/Bayer Schering Pharma Restricted Full submission
tinzaparin sodium (Innohep) 1061/15 LEO Pharmaceuticals Accepted Full submission
rivaroxaban (Xarelto) 1062/15 Bayer plc/Bayer Schering Pharma Not Recommended Full submission
cangrelor (Kengrexal) 1070/15 The Medicines Company Not Recommended Non submission
edoxaban (Lixiana) 1090/15 Daiichi Sankyo UK Ltd Accepted Full submission
edoxaban (Lixiana) 1095/15 Daiichi Sankyo UK Ltd Accepted Full submission
losartan (Cozaar) 112/04 MSD Accepted Full submission
sacubitril/valsartan (Entresto) 1132/16 Novartis Pharmaceuticals UK Ltd Accepted Full submission
alirocumab (Praluent) 1147/16 Sanofi-Aventis Restricted Full submission
evolocumab (Repatha) 1148/16 Amgen Ltd Not Recommended Full submission
evolocumab (Repatha) 1148/16 Amgen Ltd Restricted Resubmission
idarucizumab (Praxbind) 1178/16 Boehringer Ingelheim Ltd Accepted Full submission
Valsartan/hydrochlorothiazide (Co-Diovan®) 121/04 Novartis Pharmaceuticals UK Ltd Accepted Full submission
vernakalant (Brinavess) 1222/17 Cardiome UK Limited Not Recommended Non submission
ticagrelor (Brilique) 1224/17 AstraZeneca UK Ltd Not Recommended Full submission
selexipag (Uptravi) 1235/17 Actelion Pharmaceuticals UK Ltd Not Recommended Full submission
drotrecogin alfa [activated] (Xigris®) 13/02 Eli Lilly and Company Ltd Withdrawn Full submission
losartan (Cozaar) 131/04 MSD Restricted Full submission
Eplerenone (Inspra®) 136/04 Pfizer Ltd Accepted Resubmission
Eplerenone (Inspra®) 136/04 Pfizer Ltd Restricted Full submission
Omega-3-acid ethyl esters for (Omacor) 15/02 Solvay Healthcare Ltd Accepted Full submission
Bivalirudin 250mg for injection or infusion (Angiox®) 156/05 Nycomed UK Ltd Restricted Full submission
Omega-3-acid ethyl esters (Omacor®) 16/02 Solvay Healthcare Ltd Not Recommended Full submission
Candesartan cilexetil (Amias®) 161/05 Takeda UK Ltd Accepted Full submission
Valsartan 40mg, 80mg and 160mg capsules and tablets (Diovan®) 162/05 Novartis Pharmaceuticals UK Ltd Restricted Full submission
TachoSil® 168/05 Nycomed UK Ltd Accepted Full submission
fondaparinux (Arixtra) 18/02 Sanofi-Aventis Accepted Full submission
ezetimibe/simvastatin (Inegy) 182/05 MSD/Schering Plough Restricted Abbreviated Submission
Atorvastatin (Lipitor®) 202/05 Pfizer Ltd Restricted Abbreviated Submission
Bemiparin, 2500 IU in 0.2 ml injection for sub-cutaneous administration (Zibor®) 203/05 Amdipharm PLC Not Recommended Full submission
Bemiparin, 3500 IU in 0.2 ml injection for sub-cutaneous administration (Zibor®) 204/05 Amdipharm PLC Not Recommended Full submission
bemiparin 3500 IU in 0.2ml injection for sub-cutaneous administration (Zibor) 204/05 Pan Quimica Farmaceutica S.A. Not Recommended Resubmission
bemiparin 3,500 IU in 0.2ml solution for injection in prefilled syringes (Zibor) 204/05 Archimedes Pharma UK Ltd Accepted Resubmission
Bemiparin, 2500 IU in 0.2 ml and 3500 IU in 0.2 ml, injection for sub-cutaneous administration (Zibor®) 205/05 Amdipharm PLC Not Recommended Full submission
Bemiparin, 25,000 IU/ml injection for sub-cutaneous administration 206/05 Amdipharm PLC Not Recommended Full submission
bemiparin 25,000 IU/ml injection for sub-cutaneous administration (Zibor) 206/05 Pan Quimica Farmaceutica S.A. Not Recommended Resubmission
nebivolol tablets 5mg (Nebilet) 214/05 Menarini Pharmaceuticals UK Not Recommended Full submission
nebivolol tablets 5mg (Nebilet) 214/05 A Menarini Pharmaceuticals UK Ltd Accepted Resubmission
Iloprost trometamol nebuliser solution (Ventavis®) 219/05 Schering Health Care Ltd Restricted Full submission
Olmesartan/hydrochlorothiazide tablets (Olmetec Plus®) 225/05 Sankyo Pharma UK Ltd Restricted Abbreviated Submission
Sildenafil citrate 20mg tablets (Revatio®) 235/06 Pfizer Ltd Restricted Full submission
fondaparinux (Arixtra) 261/06 GlaxoSmithKline UK Ltd Not Recommended Non submission
fondaparinux (Arixtra) 262/06 GlaxoSmithKline UK Ltd Not Recommended Non submission
fondaparinux, 2.5mg/0.5ml, solution for injection (Arixtra) 287/06 GlaxoSmithKline UK Ltd Not Recommended Full submission
losartan (Cozaar) 295/06 MSD Accepted Abbreviated Submission
losartan hydrochlorothiazide (Cozaar) 296/06 MSD Accepted Abbreviated Submission
lercanidipine 20mg tablet (Zanidip) 315/06 Recordati Pharmaceuticals Accepted Abbreviated Submission
ivabradine 5mg, 7.5mg tablets (Procoralan) 319/06 Servier Laboratories Ltd Not Recommended Full submission
Ivabradine (Procoralan®) 319/06 Servier Laboratories Ltd Restricted Resubmission
Bosentan (Tracleer®) 32/03 Actelion Pharmaceuticals UK Ltd Restricted Full submission
TachoSil medicated sponge 344/07 Nycomed UK Ltd Accepted Full submission
amlodipine besylate/valsartan (Exforge®) 350/07 Novartis Pharmaceuticals UK Ltd Accepted Abbreviated Submission
valsartan (Diovan) 351/07 Novartis Pharmaceuticals UK Ltd Accepted Abbreviated Submission
sitaxentan 100mg tablets (Thelin) 360/07 Encysive (UK) Ltd Withdrawn Full submission
Irbesartan (Aprovel®) 38/03 Sanofi-Aventis Restricted Full submission
enoxaparin (Clexane) 380/07 Sanofi-Aventis Accepted Full submission
Telmisartan/hydrochlorothiazide (MicardisPlus®) 39/03 Boehringer Ingelheim Ltd Restricted Full submission
clopidogrel 75mg tablets (Plavix) 390/07 Sanofi-Aventis Restricted Full submission
fondaparinux (Arixtra) 420/07 GlaxoSmithKline UK Ltd Accepted Full submission
fondiparinux sodium (Arixtra) 439/08 GlaxoSmithKline UK Ltd Accepted Full submission
rosuvastatin (Crestor®) 45/03 AstraZeneca UK Ltd Accepted Full submission
colesevelam hydrochloride (Cholestagel) 451/08 Genzyme Therapeutics Ltd Not Recommended Non submission
aliskiren (Rasilez) 462/08 Novartis Pharmaceuticals UK Ltd Not Recommended Non submission
aliskiren (Rasilez) 462/08 Novartis Pharmaceuticals UK Ltd Not Recommended Full submission
aliskiren (Rasilez) 462/08 Novartis Pharmaceuticals UK Ltd Not Recommended Resubmission
dabigatran Etexilate (Pradaxa) 466/08 Boehringer Ingelheim Ltd Accepted Full submission
perindopril (Coversyl arganine) 2.5mg 5mg 10mg tablets 473/08 Servier Laboratories Ltd Accepted Abbreviated Submission
perindopril in combination with indapamine (Coversyl plus) 5mg/1.25mg tablet 474/08 Servier Laboratories Ltd Accepted Abbreviated Submission
bosentan 62.5mg 125mg film coated tablets (Tracleer) 485/08 Actelion Pharmaceuticals UK Ltd Not Recommended Non submission
ambrisentan (Volibris) 511/08 GlaxoSmithKline UK Ltd Restricted Full submission
bivalirudin (Angiox) 516/08 The Medicines Company Restricted Full submission
rivaroxaban (Xarelto) 519/08 Bayer plc/Bayer Schering Pharma Accepted Full submission
flecainide 200mg caps (Tambocor XL) 521/08 Meda Pharmaceuticals Ltd Accepted Abbreviated Submission
bosentan (Tracleer) 523/08 Actelion Pharmaceuticals UK Ltd Not Recommended Non submission
prasugrel (Efient) 562/09 Daiichi Sankyo UK Ltd Restricted Full submission
ranolazine (Ranexa) 565/09 A Menarini Pharmaceuticals UK Ltd Not Recommended Full submission
ranolazine (Ranexa) 565/09 A Menarini Pharmaceuticals UK Ltd Not Recommended Resubmission
ranolazine (Ranexa) 565/09 A Menarini Pharmaceuticals UK Ltd Not Recommended Resubmission
ranolazine (Ranexa) 565/09 A Menarini Pharmaceuticals UK Ltd Not Recommended IRP
olmesartan medoximil / amlodipine besilate (Sevikar) 574/09 Daiichi Sankyo UK Ltd Accepted Abbreviated Submission
sildenafil (Revatio) 596/10 Pfizer Ltd Restricted Full submission
ezetimibe (Ezetrol) 61/03 MSD/Schering Plough Restricted Full submission
nicotinic acid/laropiprant (Tredaptive) 614/10 MSD Suspended Full submission
telmisartan (Micardis) 631/10 Boehringer Ingelheim Ltd Not Recommended Non submission
dronedarone (Multaq) 636/10 Sanofi-Aventis Restricted Full submission
bivalirudin (Angiox) 638/10 The Medicines Company Restricted Full submission
Perindopril/ Indapamide (Coversyl Plus®) 64/03 Servier Laboratories Ltd Accepted Full submission
valsartan (Diovan) 649/10 Novartis Pharmaceuticals UK Ltd Restricted Abbreviated Submission
fondaparinux sodium (Arixtra) 668/10 GlaxoSmithKline UK Ltd Not Recommended Non submission
dabigatran (Pradaxa) 672/11 Boehringer Ingelheim Ltd Accepted Full submission
dalteparin (Fragmin) 683/11 Pfizer Ltd Restricted Full submission
sildenafil (Revatio) IV 688/11 Pfizer Ltd Restricted Abbreviated Submission
ivabradine (Procoralan) 689/11 Servier Laboratories Ltd Not Recommended Non submission
colesevelam (Cholestagel) 690/11 Genzyme Therapeutics Ltd Not Recommended Non submission
olmesartan medoxomil hydrochlorothiazide (Sevikar HCT) 706/11 Daiichi Sankyo UK Ltd Accepted Abbreviated Submission
tadalafil (Adcirca) 710/11 Lilly UK Not Recommended Non submission
tadalafil (Adcirca) 710/11 Eli Lilly and Company Ltd Accepted Full submission
alteplase (Actilyse) 714/11 Boehringer Ingelheim Ltd Accepted Full submission
alteplase (Actilyse Cathflo 2mg) 717/11 Boehringer Ingelheim Ltd Restricted Abbreviated Submission
rosuvastatin (Crestor) 725/11 AstraZeneca UK Ltd Not Recommended Full submission
apixaban (Eliquis) 741/11 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Full submission
rivaroxaban (Xarelto) DVT 755/12 Bayer plc/Bayer Schering Pharma Accepted Full submission
rivaroxaban (Xarelto) atrial 756/12 Bayer plc/Bayer Schering Pharma Restricted Full submission
Fluvastatin (Lescol) 76/04 Novartis Pharmaceuticals UK Ltd Restricted Full submission
atorvastatin (Lipitor) 766/12 Pfizer Ltd Accepted Abbreviated Submission
Olmesartan medoxomil (Olmetec®) 78/03 Sankyo Pharma UK Ltd Restricted Full submission
eplerenone (Inspra) 793/12 Pfizer Ltd Accepted Full submission
azilsartan medoxomil (Edarbi) 803/12 Takeda UK Ltd Not Recommended Non submission
ivabradine (Procoralan) 805/12 Servier Laboratories Ltd Restricted Full submission
sildenafil (Revatio) 809/12 Pfizer Ltd Restricted Abbreviated Submission
argatroban (Exembol) 812/12 Mitsubishi Pharma Europe Ltd Not Recommended Full submission
argatroban, 100mg/ml, concentrate for solution for infusion (Exembol®) 812/12 Mitsubishi Pharma Europe Ltd Accepted Resubmission
olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide (Sevikar HCT) 823/12 Daiichi Sankyo UK Ltd Accepted Abbreviated Submission
apixaban (Eliquis) 836/13 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Full submission
mannitol (Bronchitol) 837/13 Pharmaxis Pharmaceuticals Ltd Restricted Resubmission
rivaroxaban (Xarelto) 852/13 Bayer plc/Bayer Schering Pharma Accepted Full submission
Cilostazol (Pletal®) 86/04 Otsuka Pharmaceutical Europe Superseded Resubmission
Cilostazol (Pletal®) 86/04 Otsuka Pharmaceutical Europe Not Recommended Full submission
Alteplase (Actilyse®) 87/04 Boehringer Ingelheim Ltd Restricted Full submission
Clopidogrel (Plavix®) 88/04 Sanofi-Aventis Restricted Full submission
Nicotinic acid modified release tablet (Niaspan®) 93/04 Merck Serono Ltd Not Recommended Resubmission
Nicotinic acid modified release tablets (Niaspan®) 93/04 Merck Serono Ltd Not Recommended Full submission
Nicotonic acid modified release tabs (Niaspan®) 93/04 Merck Serono Ltd Not Recommended Resubmission
macitentan (Opsumit) 952/14 Actelion Pharmaceuticals UK Ltd Restricted Full submission
lomitapide (Lojuxta) 956/14 Not Recommended Non submission
defibrotide (Defitelio®) 967/14 Accepted Full submission
dabigatran etexilate (Pradaxa) 995/14 Boehringer Ingelheim Ltd Accepted Full submission

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