Diclofenac Siromed [Diclofenac Sopharma]

Medicinal product

(Invented) name

Diclofenac Siromed [Diclofenac Sopharma]

Active substance (s)

Diklofenako natrio druska

Strength

10 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

2014-10-16

Date of renewal

2019-11-21

Documents

3636 Pakuotės lapelis 2024 11 05.docx

3636 Diclofenac Siromed RPP 2024 11 05.docx

Diclofenac VVB_AR.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g gelio yra	1 g
Diklofenako natrio druska	10 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
58220	72362	1072362	tūbelė	40 g N1		Nereceptinis	LT/1/14/3636/001	Netiekiama	-	-	No	-	-	Download
60421	74698	1074698	tūbelė	60 g N1		Nereceptinis	LT/1/14/3636/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-11-21	Perregistruotas
2014-10-16	Registruotas