ACTILYSE

This brand name is authorized in the following countries: Austria Brazil Cyprus Ecuador Estonia Spain Finland France Hong Kong Ireland 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):

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
 
Medicines & Healthcare Products Regulatory Agency (GB)
Summary of Product Characteristics (SPC)
Medicines & Healthcare Products Regulatory Agency (GB)
Summary of Product Characteristics (SPC)

Medicine classification

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

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

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