Sodium oxybate Kalceks

Medicinal product

(Invented) name

Sodium oxybate Kalceks

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

AS Kalceks, Latvija

Date of authorisation

2019-10-01

Date of renewal

2024-01-19

Documents

4444 Sodium oxybate Kalceks PL 2024 10 01, VRA_17041.docx

Sodium oxybate Kalceks_paciento kortele.pdf

Sodium oxybate Kalceks_paciento brosiura.pdf

Sodium oxybate Kalceks_gydymo pradzios ir tolesniu vizitu forma.pdf

Sodium oxybate Kalceks_daznai uzduodami klausimai.pdf

4444 Pakuotės lapelis 2024 10 01.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10(1)

Procedure number

EE/H/0283/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

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
102454	88555	1088555	buteliukas	180 ml, adapteris, dozavimo pipetė ir 2 dozavimo taurelės N1		Receptinis	LT/1/19/4444/001	Netiekiama	2025-03-10	2025-12-31	Yes	2025-07-04	2025-12-31	Download

Stadijos

Data	Stadija
2024-01-19	Perregistruotas
2019-10-01	Registruotas