Fluorouracil EBEWE

Medicinal product

(Invented) name

Fluorouracil EBEWE

Active substance (s)

Fluorouracilas

Strength

50 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į arteriją

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BC02, Fluorouracil

Marketing authorisation holder

Ebewe Pharma Ges.m.b.H. Nfg. KG, Austrija

Date of authorisation

1996-10-30

Date of renewal

2007-05-09

Documents

0734_1_5 Fluorouracil EBEWE RPP 160405.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml paruošto 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
22734	3231	1003231	flakonas	flakonas (5 ml), N1		Receptinis	LT/1/96/0734/001	Netiekiama	-	-	No	-	-
6898	2	1000002	flakonas	flakonas (10 ml), N1		Receptinis	LT/1/96/0734/002	Netiekiama	-	-	No	-	-
22735	3848	1003848	flakonas	flakonas (20 ml), N1		Receptinis	LT/1/96/0734/003	Netiekiama	-	-	No	-	-
22736	3850	1003850	ampulė	ampulė (5 ml), N5		Receptinis	LT/1/96/0734/004	Netiekiama	-	-	No	-	-	Download
22737	3851	1003851	ampulė	ampulė (10 ml), N5		Receptinis	LT/1/96/0734/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-05	Išregistruotas
2007-05-09	Perregistruotas
1996-10-30	Registruotas