Topotecan Actavis

Medicinal product

(Invented) name

Topotecan Actavis

Active substance (s)

Topotekanas

Strength

4 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2009-07-24

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for concentrate for solution for infusion	1 vnt.
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
37072	50691	1050691	buteliukas	N1		Receptinis	EU/1/09/536/002	Netiekiama	-	-	No	-	-
50447	64333	1064333	buteliukas	N5x1		Receptinis	EU/1/09/536/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-01-15	Išregistruotas
2009-07-24	Registruotas