Akynzeo

Medicinal product

(Invented) name

Akynzeo

Active substance (s)

Netupitantas/Palonosetronas

Strength

300 mg/0,5 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

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

Hard capsules	1 vnt.
Netupitantas	300 mg
Palonosetronas	0,5 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
62352	76759	1076759	lizdinė plokštelė	N1		Receptinis	EU/1/15/1001/001	Tiekiama	-	-	No	-	-
99658	85765	1085765	dalomoji lizdinė plokštelė	N4x1		Receptinis	EU/1/15/1001/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-05-27	Registruotas