Topotecan Accord

Medicinal product

(Invented) name

Topotecan Accord

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)

L01CE01, topotecan

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2012-05-09

Date of renewal

2018-06-08

Documents

2932 Pakuotės lapelis 2025 09 18.docx

2932 Topotecan Accord PCS PL 2025 09 18.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

IE/H/0757/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato infuziniam tirpalui yra	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
44287	58080	1058080	flakonas	1 ml N1		Receptinis	LT/1/12/2932/001	Netiekiama	2026-01-01	2026-06-30	Yes	2026-01-01	2026-06-30
44288	58081	1058081	flakonas	1 ml N5		Receptinis	LT/1/12/2932/002	Netiekiama	-	-	No	-	-
52425	66346	1066346	flakonas	4 ml N1		Receptinis	LT/1/12/2932/003	Tiekiama	-	-	No	-	-
52426	66347	1066347	flakonas	4 ml N5		Receptinis	LT/1/12/2932/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-06-08	Perregistruotas
2012-05-09	Registruotas