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

UAB Niromed, Lietuva

Date of authorisation

2024-02-28

Date of renewal

Documents

2092_Topotecan Accord_2024-08-22_K.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
112986	99104	1099104	flakonas	4 ml N1		Receptinis	LT/L/24/2092/001	Netiekiama	2024-12-17	2025-06-30	Yes	2025-01-01	2025-06-30	Download

Stadijos

Data	Stadija
2024-02-28	Registruotas