Eribulin Accord

Medicinal product

(Invented) name

Eribulin Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2026-06-25

Date of renewal

Documents

6066_pakuotes lapelis_2026-06-25.docx

6066_Eribulin Accord.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/8009/001/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
121435	107542	1107542	flakonas	2 ml N1		Receptinis	LT/1/26/6066/001	Netiekiama	-	-	No	-	-
121436	107543	1107543	flakonas	2 ml N6		Receptinis	LT/1/26/6066/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-06-25	Registruotas