Fludara

Medicinal product

(Invented) name

Fludara

Active substance (s)

Fludarabinas

Strength

10 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BB05, Fludarabine

Marketing authorisation holder

Sanofi B.V., Nyderlandai

Date of authorisation

2002-02-06

Date of renewal

2012-02-28

Documents

2819 Pakuotės lapelis 2024 04 02.docx

2819 Fludara 10mg tab RPP 2024 04 02.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Fludarabinas	10 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
2592	4848	1004848	lizdinė plokštelė	N15		Receptinis	LT/1/96/2819/001	Netiekiama	-	-	No	-	-
2593	4849	1004849	lizdinė plokštelė	N20		Receptinis	LT/1/96/2819/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2012-02-28	Perregistruotas
2002-02-06	Registruotas