Metalyse

Medicinal product

(Invented) name

Metalyse

Active substance (s)

Tenekteplazė

Strength

10 000 V (50 mg)

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AD11, Tenecteplase

Marketing authorisation holder

Boehringer Ingelheim International GmbH, Vokietija

Date of authorisation

2002-09-18

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for solution for injection	1 vnt.
Tenekteplazė	10 000 V (50 mg)

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
27125	29682	1029682	flakonas	milteliai (50 mg), tirpiklio užpildytas švirkštas (10 ml), flakono adapteris N1		Receptinis	EU/1/00/169/006	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-09-18	Registruotas