Fludarabine Actavis

Medicinal product

(Invented) name

Fludarabine Actavis

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2013-07-11

Date of renewal

2018-07-30

Documents

3338_1-2 Pakuotes lapelis_2018-07-30.docx

3338_1-2 Fludarabine Actavis_perr20180730.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

UK/H/5290/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename ml koncentrato 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
52739	66672	1066672	flakonas	2 ml N1		Receptinis	LT/1/13/3338/001	Netiekiama	-	-	No	-	-
56691	70795	1070795	flakonas	2 ml N5		Receptinis	LT/1/13/3338/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-05	Išregistruotas
2018-07-30	Perregistruotas
2013-07-11	Registruotas