Fludarabine Accord

Medicinal product

(Invented) name

Fludarabine Accord

Active substance (s)

Fludarabinas

Strength

25 mg/ml

Pharmaceutical form

koncentratas injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BB05, Fludarabine

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2014-10-10

Date of renewal

2023-06-15

Documents

3627 Fludarabine Accord II PL 2025 07 30.docx

3627 Pakuotės lapelis 2025 07 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/4563/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename ml yra	1 ml
Fludarabinas	25 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
56850	70957	1070957	flakonas	2 ml N1		Receptinis	LT/1/14/3627/001	Tiekiama	2025-06-03	-	No	-	-
60391	74668	1074668	flakonas	2 ml N5		Receptinis	LT/1/14/3627/002	Netiekiama	-	-	No	-	-
60392	74669	1074669	flakonas	2 ml N10		Receptinis	LT/1/14/3627/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-15	Perregistruotas
2014-10-10	Registruotas