Topotecan Teva

Medicinal product

(Invented) name

Topotecan Teva

Active substance (s)

Topotekanas

Strength

1 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)

L01XX17, Topotecan

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2009-09-21

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

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	1 ml
Topotekanas	1 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
37153	5563	1005563	buteliukas	1 ml N1		Receptinis	EU/1/09/552/001	Netiekiama	-	-	No	-	-
37154	5771	1005771	buteliukas	1 ml N5		Receptinis	EU/1/09/552/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-04-15	Išregistruotas
2009-09-21	Registruotas