Monteplase was approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on March 14, 2008. It was developed and marketed as Cleactor® by Eisai.
Monteplase is a tissue plasminogen activator, which binds to fibrin in a thrombus and converts the entrapped plasminogen to plasmin. It is indicated for the treatment of patients with acute myocardial infarction and acute massive pulmonary embolism.
Cleactor® is available as injection (lyophilized powder) for intravenous use, containing 400000 IU, 800000 IU or 1200000 IU of Monteplase. The recommended dose is 27500 IU/kg for acute myocardial infarction, 13750-27500 IU/kg for acute massive pulmonary embolism.
Update Date:2015-10-30
Update Date:2015-09-07
Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
---|---|---|---|---|---|---|---|
2008-03-14 | Marketing approval | Cleactor | Acute myocardial infarction (AMI), Acute massive pulmonary embolism | Injection, Lyophilized powder, For solution | 400000 IU; 800000 IU; 1200000 IU | Eisai | Orphan |
Update Date:2015-09-07
Type | Recombinant enzyme | |
Source | Human | |
Molecular Formula | C2569H3896N746O783S39; C2580H3916N752O786S39 | |
Molecular Weight | ~68000 | |
CAS No. | 105913-11-9 | |
Expression System | Mammalian Cell |