Dekenor

Medicinal product

(Invented) name

Dekenor

Active substance (s)

Deksketoprofenas

Strength

50 mg/2 ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M01AE17, Dexketoprofen

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2018-05-08

Date of renewal

2024-04-24

Documents

4218_Dekenor_perr2024-04-24.docx

4218_pakuotes lapelis_2024-04-24.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/1804/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Ampulėje (2 ml) tirpalo yra	2 ml
Deksketoprofenas	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
99451	85558	1085558	ampulė	2 ml N1		Receptinis	LT/1/18/4218/001	Netiekiama	-	-	No	-	-
99452	85559	1085559	ampulė	2 ml N5		Receptinis	LT/1/18/4218/002	Tiekiama	-	-	No	-	-
99453	85560	1085560	ampulė	2 ml N10		Receptinis	LT/1/18/4218/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-24	Perregistruotas
2018-05-08	Registruotas