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Category: 2.8 Anticoagulants and protamine

Name SMC ID No Manufacturer Status Sub. Type
 
apixaban (Eliquis) 1029/15 Pfizer/Bristol Myers Squbb Accepted 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
edoxaban (Lixiana) 1090/15 Daiichi Sankyo UK Ltd Accepted Full submission
edoxaban (Lixiana) 1095/15 Daiichi Sankyo UK Ltd Accepted Full submission
idarucizumab (Praxbind) 1178/16 Boehringer Ingelheim Ltd Accepted Full submission
Bivalirudin 250mg for injection or infusion (Angiox®) 156/05 Nycomed UK Ltd Restricted Full submission
fondaparinux (Arixtra) 18/02 Sanofi-Aventis Accepted Full 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, 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
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
enoxaparin (Clexane) 380/07 Sanofi-Aventis Accepted Full submission
fondaparinux (Arixtra) 420/07 GlaxoSmithKline UK Ltd Accepted Full submission
fondiparinux sodium (Arixtra) 439/08 GlaxoSmithKline UK Ltd Accepted Full submission
dabigatran Etexilate (Pradaxa) 466/08 Boehringer Ingelheim Ltd Accepted Full submission
bivalirudin (Angiox) 516/08 The Medicines Company Restricted Full submission
rivaroxaban (Xarelto) 519/08 Bayer plc/Bayer Schering Pharma Accepted Full submission
bivalirudin (Angiox) 638/10 The Medicines Company Restricted Full 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
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
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
apixaban (Eliquis) 836/13 Bristol-Myers Squibb Pharmaceuticals Ltd Accepted Full submission
rivaroxaban (Xarelto) 852/13 Bayer plc/Bayer Schering Pharma Accepted Full submission
dabigatran etexilate (Pradaxa) 995/14 Boehringer Ingelheim Ltd Accepted Full submission

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