Eribulin ADVZ

Medicinal product

(Invented) name

Eribulin ADVZ

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

Advanz Pharma Limited, Airija

Date of authorisation

2023-08-03

Date of renewal

Documents

5229 Pakuotes lapelis 2024 08 19.docx

5229 Eribulin ADVZ RPP 2024 08 19.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0536/001/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
111449	97562	1097562	flakonas	2 ml N1		Receptinis	LT/1/23/5229/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-08-03	Registruotas