Oxiore

Medicinal product

(Invented) name

Oxiore

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

UAB Niromed, Lietuva

Date of authorisation

2026-08-25

Date of renewal

Documents

3564_Oxiore 500mg-ml_ger_tirp_PL_2026-08-25.docx

3564_Oxiore 500mg-ml_ger_tirp_PZ_2026-08-25.docx

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

1 ml tirpalo yra	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
122052	108160	1108160	buteliukas	180 ml, adapteris, dozavimo švirkštas ir 2 dozavimo taurelės N1		Receptinis	LT/L/26/3564/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2026-08-25	Registruotas