Alteplase is a prescription medicine indicated for the treatment of acute Ischemic Stroke (AIS), among other approved uses. It is available as kits and powder for injection for intravenous use. MedsAcross supplies Alteplase for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Activase is a tissue plasminogen activator (tPA) indicated for the treatment of: Acute Ischemic Stroke (AIS). Acute Myocardial Infarction (AMI) to reduce mortality and incidence of heart failure. Limitation of Use in AMI: the risk of stroke may be greater than the benefit in patients at low risk of death from cardiac causes. Acute Massive Pulmonary Embolism (PE) for lysis.
Source: US FDA prescribing information
Alteplase is a serine protease responsible for fibrin-enhanced conversion of plasminogen to plasmin. It produces limited conversion of plasminogen in the absence of fibrin. When introduced into the systemic circulation at pharmacologic concentration, alteplase binds to fibrin in a thrombus and converts the entrapped plasminogen to plasmin. This initiates local fibrinolysis with limited systemic proteolysis.
Source: US FDA prescribing information
Acute Ischemic Stroke: The recommended dose is 0.9 mg/kg (not to exceed 90 mg total dose) infused intravenously over 60 minutes with 10% of the total dose administered as an initial bolus over 1 minute. Acute Myocardial Infarction: The recommended total dose is based on patient weight, not to exceed 100 mg. Acute Massive Pulmonary Embolism: The recommended dose is 100 mg administered by IV infusion over 2 hours. Do not add other medications to infusions containing Activase.
Source: US FDA prescribing information
General Active internal bleeding. Recent intracranial or intraspinal surgery or serious head trauma. Intracranial conditions that may increase the risk of bleeding. Bleeding diathesis. Current severe uncontrolled hypertension. Acute Ischemic Stroke Current intracranial hemorrhage. Subarachnoid hemorrhage. Acute Myocardial Infarction or Pulmonary Embolism History of recent stroke.
Source: US FDA prescribing information
Increases the risk of bleeding. Avoid intramuscular injections. Monitor for bleeding. If serious bleeding occurs, discontinue Activase. Monitor patients during and for several hours after infusion for hypersensitivity. If signs of hypersensitivity develop, discontinue Activase. Consider the risk of reembolization from the lysis of underlying deep venous thrombi in patients with pulmonary embolism. Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in the other sections of the label: Bleeding Hypersensitivity Thromboembolism Cholesterol Embolization The most frequently occurring adverse reaction ( > 5%) is bleeding.
Source: US FDA prescribing information
The interaction of Activase with other cardioactive or cerebroactive drugs has not been studied. Anticoagulants and antiplatelet drugs increase the risk of bleeding if administered prior to, during, or after Activase therapy. In the post-marketing setting, there have been reports of angioedema in patients (primarily patients with AIS) receiving concomitant angiotensin-converting enzyme inhibitors. Anticoagulants and drugs that inhibit platelet function increase the risk of bleeding when administered with Activase therapy. Concomitant angiotensin-converting enzyme inhibitors may increase the risk of angioedema.
Source: US FDA prescribing information
Storage Store lyophilized Activase at controlled room temperature not to exceed 30°C (86°F), or under refrigeration at 2° to 8°C (36° to 46°F). Protect the lyophilized material during extended storage from excessive exposure to light. If stored between 2-30°C (36-86°F), Activase may be used within 8 hours following reconstitution.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Alteplase, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Activase kit Cold chain | Genentech | US FDA | Available on request |
| Cathflo Activase 2.2 mg/2 mL powder for injectionIntravenous | Genentech | US FDA | Available on request |
2 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 13 November 1987 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Alteplase in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Alteplase and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Alteplase, including Activase, Cathflo Activase.
Yes. The US FDA first approved Alteplase on 13 November 1987, according to Drugs@FDA.
At least one listed presentation of Alteplase must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Alteplase is classified under ATC code B01AD02 (Alteplase).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.