Topotecan Hospira

Medicinal product

(Invented) name

Topotecan Hospira

Active substance (s)

Topotekanas

Strength

4 mg/4 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)

L01CE01, topotecan

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2010-06-10

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	4 ml
Topotekanas	4 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
41877	55640	1055640	flakonas	4 ml N1		Receptinis	EU/1/10/633/001	Netiekiama	-	-	No	-	-
41878	55641	1055641	flakonas	4 ml N5		Receptinis	EU/1/10/633/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-06-10	Registruotas