FLUOROURACIL-TEVA

Medicinal product

(Invented) name

FLUOROURACIL-TEVA

Active substance (s)

Fluorouracilas

Strength

50 mg/ml

Pharmaceutical form

injekcinis 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

Teva Pharma B.V., Nyderlandai

Date of authorisation

1998-03-31

Date of renewal

2013-05-29

Documents

0536_1_2 FLUOROURACIL_TEVA inj RPP 151112.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalas 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
15937	4718	1004718	flakonas	5 ml N1 (250 mg/5 ml)		Receptinis	LT/1/98/0536/001	Netiekiama	-	-	No	-	-	Download
15938	20025	1020025	flakonas	5 ml N5 (250 mg/5 ml)		Receptinis	LT/1/98/0536/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-01-07	Išregistruotas
2013-05-29	Perregistruotas
1998-03-31	Registruotas