METALYSE

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

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 more about Tenecteplase

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
METALYSE Powder and solvent for solution for injection	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

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