Diclac

Medicinal product

(Invented) name

Diclac

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

Sandoz d.d., Slovėnija

Date of authorisation

2023-04-27

Date of renewal

Documents

5177 Pakuotės lapelis 2024 10 24.docx

5177 Diclac 23,2mg PCS PL 2024 10 24, PZ rastas 8608.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

HU/H/0745/001/DC

Marketing authorisation procedure

Decentralizuota 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
110930	97041	1097041	tūbelė	50 g N1		Nereceptinis	LT/1/23/5177/001	Netiekiama	-	-	No	-	-
110931	97042	1097042	tūbelė	100 g N1		Nereceptinis	LT/1/23/5177/002	Netiekiama	-	-	No	-	-
110932	97043	1097043	tūbelė	150 g N1		Nereceptinis	LT/1/23/5177/003	Netiekiama	-	-	No	-	-
110933	97044	1097044	tūbelė	180 g N1		Nereceptinis	LT/1/23/5177/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-27	Registruotas