5-FU medac

Medicinal product

(Invented) name

5-FU medac

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

UAB Niromed, Lietuva

Date of authorisation

2025-07-17

Date of renewal

Documents

2698_5-FU medac 50mgml inj inf tirp 20ml N1_PZ_2025-07-17.docx

2698_5-FU medac 50mgml inj inf tirp 20ml N1_PIL_2025-07-17.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
118181	104289	1104289	flakonas	20 ml N1		Receptinis	LT/L/25/2698/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2025-07-17	Registruotas