Oxycodone Kalceks

Medicinal product

(Invented) name

Oxycodone Kalceks

Active substance (s)

Oksikodono hidrochloridas

Strength

50 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02AA05, Oxycodone

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2018-12-14

Date of renewal

2023-06-21

Documents

4309_4310 Oxycodone Kalceks PCS PL 2025 03 27.docx

4309_4310 Pakuotės lapelis 2025 03 27.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

EE/H/0259/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Oksikodono hidrochloridas	50 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
100688	86798	1086798	ampulė	1 ml N5		Receptinis	LT/1/18/4310/001	Netiekiama	-	-	No	-	-
100689	86799	1086799	ampulė	1 ml N10		Receptinis	LT/1/18/4310/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-21	Perregistruotas
2018-12-14	Registruotas