Fludarabina Accord

Medicinal product

(Invented) name

Fludarabina 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

UAB Niromed, Lietuva

Date of authorisation

2025-04-30

Date of renewal

Documents

2532_Fludarabina Accord 25 mgml konc inj ar inf tirp_PZ_2025-04-30.docx

2532_Fludarabina Accord 25 mgml konc inj ar inf tirp_PL_2025-04-30.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
117432	103537	1103537	flakonas	2 ml N1		Receptinis	LT/L/25/2532/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2025-04-30	Registruotas