HETLIOZ

Medicinal product

(Invented) name

HETLIOZ

Active substance (s)

Tazimelteonas

Strength

20 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)

N05CH03, Tasimelteon

Marketing authorisation holder

Vanda Pharmaceuticals Netherlands B.V., Nyderlandai

Date of authorisation

2015-07-03

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 capsule	1 vnt.
Tazimelteonas	20 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
62939	77353	1077353	buteliukas	N30		Receptinis	EU/1/15/1008/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-07-03	Registruotas