Dolmen

Medicinal product

(Invented) name

Dolmen

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

Menarini International Operations Luxembourg S.A., Liuksemburgas

Date of authorisation

2006-09-11

Date of renewal

2008-01-17

Documents

0539 Dolmen 50mg_2ml inj_inf II PL 2024 08 21.docx

0539 Pakuotės lapelis 2024 08 21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

ES/H/0101/003/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Ampulėje (2 ml) 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
17979	21722	1021722	ampulė	2 ml N1		Receptinis	LT/1/06/0539/013	Netiekiama	-	-	No	-	-
17980	21723	1021723	ampulė	2 ml N5		Receptinis	LT/1/06/0539/014	Tiekiama	-	-	No	-	-	Download
17981	21724	1021724	ampulė	2 ml N6		Receptinis	LT/1/06/0539/015	Netiekiama	-	-	No	-	-
17982	21725	1021725	ampulė	2 ml N10		Receptinis	LT/1/06/0539/016	Netiekiama	-	-	No	-	-
17983	21726	1021726	ampulė	2 ml N20		Receptinis	LT/1/06/0539/017	Netiekiama	-	-	No	-	-
17984	21727	1021727	ampulė	2 ml N50		Receptinis	LT/1/06/0539/018	Netiekiama	-	-	No	-	-
17985	21728	1021728	ampulė	2 ml N100		Receptinis	LT/1/06/0539/019	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-01-17	Perregistruotas
2006-09-11	Registruotas