Actilyse

Medicinal product

(Invented) name

Actilyse

Active substance (s)

Alteplazė

Strength

50 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B01AD02, Alteplase

Marketing authorisation holder

Boehringer Ingelheim International GmbH, Vokietija

Date of authorisation

1996-03-29

Date of renewal

2007-10-15

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Alteplazė	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
1770	7453	1007453	flakonas	milteliai (50 mg) ir tirpiklis (50 ml), N1		Receptinis	LT/1/96/0844/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2007-10-15	Perregistruotas
1996-03-29	Registruotas