Fluorouracil Accord

Medicinal product

(Invented) name

Fluorouracil Accord

Active substance (s)

Fluorouracilas

Strength

50 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BC02, Fluorouracil

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2010-07-29

Date of renewal

2019-05-27

Documents

2109 Pakuotės lapelis 2025 03 19.docx

2109 Fluorouracil Accord II PL 2025 03 19.docx

Fluorouracil Accord-DHPC.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4564/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Fluorouracilas	50 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
23318	26039	1026039	flakonas	5 ml N1		Receptinis	LT/1/10/2109/001	Netiekiama	-	-	No	-	-	Download
24353	27014	1027014	flakonas	10 ml N1		Receptinis	LT/1/10/2109/002	Netiekiama	-	-	No	-	-
24354	27015	1027015	flakonas	20 ml N1		Receptinis	LT/1/10/2109/003	Tiekiama	-	-	No	-	-
24355	27016	1027016	flakonas	100 ml N1		Receptinis	LT/1/10/2109/004	Tiekiama	2025-09-12	-	No	-	-
47733	61555	1061555	flakonas	50 ml N1		Receptinis	LT/1/10/2109/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-05-27	Perregistruotas
2010-07-29	Registruotas