This brand name is authorized in Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug ACTILYSE contains one active pharmaceutical ingredient (API):
1
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UNII
1RXS4UE564 - ALTEPLASE
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Alteplase is a recombinant human tissue-type plasminogen activator, a glycoprotein, which activates plasminogen directly to plasmin. Once bound to fibrin, it is activated, inducing the conversion of plasminogen to plasmin leading to the dissolution of the fibrin clot. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ACTILYSE Powder and solvent for solution | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| B01AD02 | Alteplase | B Blood and blood forming organs → B01 Antithrombotic agents → B01A Antithrombotic agents → B01AD Enzymes |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 504500101153319, 504512030018303, 504512030018403 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 29776-05-11 |
| EE | Ravimiamet | 1004128, 1700109, 1885383 |
| ES | Centro de información online de medicamentos de la AEMPS | 59494 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 387675, 404491, 404533 |
| FR | Base de données publique des médicaments | 63617876, 67177673 |
| GB | Medicines & Healthcare Products Regulatory Agency | 344939, 48386, 48398, 48453 |
| HK | Department of Health Drug Office | 30511, 37894 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-191255719, HR-H-676368257 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7364, 7365 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1007453, 1061418, 1061419 |
| MT | Medicines Authority | MA211/00901, MA211/00902, MA211/00903 |
| NL | Z-Index G-Standaard | 13250949, 13733370 |
| NL | Z-Index G-Standaard, PRK | 25747, 36870 |
| NZ | Medicines and Medical Devices Safety Authority | 13161, 4765, 4766, 4767 |
| PL | Rejestru Produktów Leczniczych | 100002579, 100002585, 100002622 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W00257001 |
| SG | Health Sciences Authority | 02340P |
| TN | Direction de la Pharmacie et du Médicament | 5253111H, 5253112H, 5253113H |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699693790026, 8699693790033, 8699693790040 |
| ZA | Health Products Regulatory Authority | U/31/229 |
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