Dexketoprofen Sopharma

Medicinal product

(Invented) name

Dexketoprofen Sopharma

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

SOPHARMA AD, Bulgarija

Date of authorisation

2020-11-25

Date of renewal

2025-04-07

Documents

4637_pakuotes lapelis_2025-04-07.docx

4637_Dexket_Sopharma _perr2025-04-07.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0200/001/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
105334	91436	1091436	ampulė	2 ml N1		Receptinis	LT/1/20/4637/001	Netiekiama	-	-	No	-	-	Download
105335	91437	1091437	ampulė	2 ml N5		Receptinis	LT/1/20/4637/002	Netiekiama	-	-	No	-	-
105336	91438	1091438	ampulė	2 ml N6		Receptinis	LT/1/20/4637/003	Netiekiama	-	-	No	-	-
105337	91439	1091439	ampulė	2 ml N10		Receptinis	LT/1/20/4637/004	Netiekiama	-	-	No	-	-
105338	91440	1091440	ampulė	2 ml N20		Receptinis	LT/1/20/4637/005	Netiekiama	-	-	No	-	-
105339	91441	1091441	ampulė	2 ml N25		Receptinis	LT/1/20/4637/006	Netiekiama	-	-	No	-	-
105340	91442	1091442	ampulė	2 ml N50		Receptinis	LT/1/20/4637/007	Netiekiama	-	-	No	-	-
105341	91443	1091443	ampulė	2 ml N100		Receptinis	LT/1/20/4637/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-07	Perregistruotas
2020-11-25	Registruotas