ACTILYSE

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 UNII 1RXS4UE564 - 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 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: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-191255719, HR-H-676368257
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