Dagesil

Medicinal product

(Invented) name

Dagesil

Active substance (s)

Diklofenako natrio druska

Strength

75 mg/3 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)

M01AB05, Diclofenac

Marketing authorisation holder

Laboratórios Basi-Indústria Farmacêutica, S.A., Portugalija

Date of authorisation

2023-10-04

Date of renewal

Documents

5244 Dagesil RPP 2025 06 27.docx

5244 Pakuotės lapelis 2025 06 27.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2779/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Ampulėje (3 ml) yra:	3 ml
Diklofenako natrio druska	75 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
111736	97851	1097851	ampulė	3 ml N50		Receptinis	LT/1/23/5244/001	Netiekiama	-	-	No	-	-
113667	99786	1099786	ampulė	3 ml N3		Receptinis	LT/1/23/5244/002	Netiekiama	-	-	No	-	-
113668	99787	1099787	ampulė	3 ml N6		Receptinis	LT/1/23/5244/003	Netiekiama	-	-	No	-	-
117928	104033	1104033	ampulė	3 ml N2		Receptinis	LT/1/23/5244/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-10-04	Registruotas