Onkotrone

Medicinal product

(Invented) name

Onkotrone

Active substance (s)

Mitoksantronas

Strength

2 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)

L01DB07, Mitoxantrone

Marketing authorisation holder

UAB Baxter Lithuania, Lietuva

Date of authorisation

1997-06-06

Date of renewal

2012-07-25

Documents

3010 Onkotrone RPP 2024 11 28.docx

3010 Pakuotės lapelis 2024 11 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Mitoksantronas	2 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
1772	7455	1007455	flakonas	5 ml N1		Receptinis	LT/1/97/3010/001	Netiekiama	-	-	No	-	-
53097	67038	1067038	flakonas	10 ml N1		Receptinis	LT/1/97/3010/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-07-25	Perregistruotas
1997-06-06	Registruotas