This brand name is authorized in Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

Active ingredients

The drug ACTILYSE contains one active pharmaceutical ingredient (API):

1 Alteplase

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.

Read about Alteplase

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
ACTILYSE Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC
ACTILYSE Powder and solvent for solution Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
B01AD02 Alteplase B Blood and blood forming organs → B01 Antithrombotic agents → B01A Antithrombotic agents → B01AD Enzymes
Discover more medicines within B01AD02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 504500101153319, 504512030018303, 504512030018403
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 29776-05-11
Country: EE Ravimiamet Identifier(s): 1004128, 1700109, 1885383
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 59494
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 387675, 404491, 404533
Country: FR Base de données publique des médicaments Identifier(s): 63617876, 67177673
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 344939, 48386, 48398, 48453
Country: HK Department of Health Drug Office Identifier(s): 30511, 37894
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 7364, 7365
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1007453, 1061418, 1061419
Country: MT Medicines Authority Identifier(s): MA211/00901, MA211/00902, MA211/00903
Country: NL Z-Index G-Standaard Identifier(s): 13250949, 13733370
Country: NL Z-Index G-Standaard, PRK Identifier(s): 25747, 36870
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 13161, 4765, 4766, 4767
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100002579, 100002585, 100002622
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W00257001
Country: SG Health Sciences Authority Identifier(s): 02340P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 5253111H, 5253112H, 5253113H
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699693790026, 8699693790033, 8699693790040
Country: ZA Health Products Regulatory Authority Identifier(s): U/31/229

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