Xyrem

Medicinal product

(Invented) name

Xyrem

Active substance (s)

Natrio oksibatas

Strength

500 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07XX04, Sodium oxybate

Marketing authorisation holder

UCB Pharma S.A., Belgija

Date of authorisation

2005-11-12

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

oral solution	1 ml
Natrio oksibatas	500 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
28914	31426	1031426	buteliukas	180 ml, adapteris, dozatorius, dozavimo taurelės ir 2 uždoriai N1		Receptinis	EU/1/05/312/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2005-11-12	Registruotas