Fasturtec

Medicinal product

(Invented) name

Fasturtec

Active substance (s)

Rasburikazė

Strength

1,5 mg/ml

Pharmaceutical form

milteliai ir tirpiklis infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V03AF07, Rasburicase

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2001-02-23

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 concentrate for solution for infusion	1 ml
Rasburikazė	1,5 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
25806	28398	1028398	flakonas	N3 (1,5 mg/1 ml) + ampulė N3		Receptinis	EU/1/00/170/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-02-23	Registruotas