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

Pierre Fabre Medicament, Prancūzija

Date of authorisation

2007-12-04

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Centrinė registracija

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
25118	27743	1027743	flakonas	10 ml, N8		Receptinis	EU/1/03/254/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-01	Išregistruotas
2007-12-04	Registruotas