Naklofen

Medicinal product

(Invented) name

Naklofen

Active substance (s)

Diklofenako dietilamonio druska

Strength

11,6 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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

1995-10-04

Date of renewal

2008-12-18

Documents

0862_5_6_Naklofen_gel_RPP_181130_keit.docx

0862_5_6_Pakuotės lapelis_181130.docx

Stage

Išregistruotas

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 dietilamonio druska	11,6 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
1223	7029	1007029	tūbelė	60 g, N1		Nereceptinis	LT/1/94/0862/005	Netiekiama	-	-	No	-	-	Download
54378	68374	1068374	tūbelė	120 g, N1		Nereceptinis	LT/1/94/0862/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-10-02	Išregistruotas
2008-12-18	Perregistruotas
1995-10-04	Registruotas