Eribulin Zentiva

Medicinal product

(Invented) name

Eribulin Zentiva

Active substance (s)

Eribulinas

Strength

0,44 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XX41, Eribulin

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2024-03-14

Date of renewal

Documents

5368 Pakuotės lapelis 2025 02 23.docx

5368 Eribulin Zentiva PCS PL 2025 02 23.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/1248/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Eribulinas	0,44 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
113186	99305	1099305	flakonas	2 ml N1		Receptinis	LT/1/24/5368/001	Tiekiama	2025-02-01	-	No	-	-
113187	99306	1099306	flakonas	2 ml N6		Receptinis	LT/1/24/5368/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-03-14	Registruotas