Akynzeo

Medicinal product

(Invented) name

Akynzeo

Active substance (s)

Fosnetupitantas/Palonosetronas

Strength

235 mg/0,25 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A04AA55, Palonosetron, combinations

Marketing authorisation holder

Helsinn Birex Pharmaceuticals Ltd., Airija

Date of authorisation

2015-05-27

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

Powder for concentrate for solution for infusion	1 vnt.
Fosnetupitantas	235 mg
Palonosetronas	0,25 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
103466	89568	1089568	flakonas	N1		Receptinis	EU/1/15/1001/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-05-27	Registruotas