HALAVEN

Medicinal product

(Invented) name

HALAVEN

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

Eisai GmbH, Vokietija

Date of authorisation

2011-03-17

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	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
45837	59639	1059639	flakonas	2 ml N1		Receptinis	EU/1/11/678/001	Tiekiama	-	-	No	-	-
45838	59640	1059640	flakonas	2 ml N6		Receptinis	EU/1/11/678/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-03-17	Registruotas