METALYSE

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

Active ingredients

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

1 Tenecteplase UNII WGD229O42W - TENECTEPLASE

Tenecteplase is a recombinant fibrin-specific plasminogen activator that is derived from native t-PA by modifications at three sites of the protein structure. It binds to the fibrin component of the thrombus (blood clot) and selectively converts thrombus-bound plasminogen to plasmin, which degrades the fibrin matrix of the thrombus. Tenecteplase has a higher fibrin specificity and greater resistance to inactivation by its endogenous inhibitor (PAI-1) compared to native t-PA. Read about Tenecteplase

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
METALYSE Powder and solvent for solution for injection	European Medicines Agency (EU)	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
B01AD11	Tenecteplase	B Blood and blood forming organs → B01 Antithrombotic agents → B01A Antithrombotic agents → B01AD Enzymes
Discover more medicines within B01AD11

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 8526R, 8527T
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 504502701158318, 504502702154316
Country: EE	Ravimiamet	Identifier(s): 1204951, 1204962, 1204973
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 00169005, 00169006
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 590919
Country: FR	Base de données publique des médicaments	Identifier(s): 65088998
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 43790
Country: HK	Department of Health Drug Office	Identifier(s): 49440
Country: IT	Agenzia del Farmaco	Identifier(s): 035370016, 035370028, 035370030, 035370042, 035370055, 035370067
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1029680, 1029681, 1029682, 1059536
Country: NL	Z-Index G-Standaard	Identifier(s): 14643596
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 58912
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 9412, 9413
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100127418, 100127430
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W13571001, W13572001
Country: SG	Health Sciences Authority	Identifier(s): 12015P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 5253114H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699693270016
Country: ZA	Health Products Regulatory Authority	Identifier(s): 34/31/0409, 34/31/0410