Rapilysin

Medicinal product

(Invented) name

Rapilysin

Active substance (s)

Reteplazė

Strength

10 V

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)

B01AD07, Reteplase

Marketing authorisation holder

Actavis Group PTC ehf., Islandija

Date of authorisation

1996-08-29

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

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.
Reteplazė	10 V

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
28080	30616	1030616	flakonas	milteliai, užpildyas švirkštas, tirpalo ruošimo įtaisas ir 19 G l adatos N2		Receptinis	EU/1/96/018/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-26	Išregistruotas
1996-08-29	Registruotas