Diclofenac diethylamine Sopharma

Medicinal product

(Invented) name

Diclofenac diethylamine Sopharma

Active substance (s)

Diklofenako dietilaminas

Strength

23,2 mg/g

Pharmaceutical form

gelis

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M02AA15, Diclofenac

Marketing authorisation holder

SOPHARMA AD, Bulgarija

Date of authorisation

2023-11-06

Date of renewal

Documents

5258 Pakuotės lapelis 2025 01 02.docx

5258 Diclofenac diethylamine Sopharma RPP 2025 01 02.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

LV/H/0209/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 g gelio yra:	1 g
Diklofenako dietilaminas	23,2 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
111896	98011	1098011	tūbelė	60 g N1		Nereceptinis	LT/1/23/5258/001	Tiekiama	2026-01-01	-	No	-	-
111897	98012	1098012	tūbelė	120 g N1		Nereceptinis	LT/1/23/5258/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-06	Registruotas