Busilvex

Medicinal product

(Invented) name

Busilvex

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

UAB Lex ano, Lietuva

Date of authorisation

2018-02-28

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

CR-Lygiagretus platinimas

Qualitative and quantitative composition

Concentrate for solution for infusion	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
99132	85238	1085238	flakonas	10 ml N8		Receptinis	EU/1/03/254/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-02-28	Registruotas