Composition

Each vial with powder contains: Alteplase 50 mg (corresponding to 29,000,000 IU). Alteplase is produced by recombinant DNA technique using a Chinese hamster ovary cell-line. The specific activity of alteplase in-house reference material is 580,000 IU/mg. This has been confirmed by comparison with the second international WHO standard for t-PA. The specification for the specific activity of alteplase is 522,000 to 696,000 IU/mg.  

ATC Code

B01AD02  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

1 x 1's  

Product Description

Powder and solvent for solution for injection and infusion. The powder is presented as a colourless to pale yellow lyophilizate cake. The reconstituted preparation is a clear and colourless to pale yellow solution

Manufacturer Name

Boehringer Ingelheim Pharma GmbH & Co. KG

Manufacturer Country

GERMANY  

Approval Date

2020-12-20  

Expiry Date

2025-12-20