Dexketoprofen Kalceks

Medicinal product

(Invented) name

Dexketoprofen Kalceks

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

AS Kalceks, Latvija

Date of authorisation

2018-01-24

Date of renewal

2022-09-09

Documents

4182 Dexketoprofen Kalceks PL 2024 10 01, VRA rastas 17041.docx

4182 Pakuotės lapelis 2024 10 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0241/001/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
98765	84869	1084869	ampulė	2 ml N1		Receptinis	LT/1/18/4182/001	Netiekiama	-	-	No	-	-
98766	84870	1084870	ampulė	2 ml N5		Receptinis	LT/1/18/4182/002	Tiekiama	-	-	No	-	-	Download
101637	87741	1087741	ampulė	2 ml N6		Receptinis	LT/1/18/4182/003	Netiekiama	-	-	No	-	-
101638	87742	1087742	ampulė	2 ml N25		Receptinis	LT/1/18/4182/004	Netiekiama	-	-	No	-	-
101639	87743	1087743	ampulė	2 ml N100		Receptinis	LT/1/18/4182/005	Netiekiama	-	-	No	-	-
102871	88972	1088972	ampulė	2 ml N10		Receptinis	LT/1/18/4182/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-09	Perregistruotas
2018-01-24	Registruotas