Busulfan Fresenius Kabi

Medicinal product

(Invented) name

Busulfan Fresenius Kabi

Active substance (s)

Busulfanas

Strength

6 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01AB01, Busulfan

Marketing authorisation holder

Fresenius Kabi Deutschland GmbH, Vokietija

Date of authorisation

2014-09-22

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Busulfanas	6 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
60235	74509	1074509	flakonas	10 ml N8 (8x1)		Receptinis	EU/1/14/951/001	Tiekiama	2025-07-11	-	No	-	-
117916	104021	1104021	flakonas	40 ml N1		Receptinis	EU/1/14/951/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-09-22	Registruotas