Olfen

Medicinal product

(Invented) name

Olfen

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

Teva B.V., Nyderlandai

Date of authorisation

1996-07-11

Date of renewal

2012-02-28

Documents

0391 Olfen 1proc gelis RPP 2024 09 05.docx

0391 Pakuotės lapelis 2024 09 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

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
13477	17774	1017774	tūbelė	50 g N1		Nereceptinis	LT/1/96/0391/007	Tiekiama	-	-	No	-	-	Download
98677	84781	1084781	tūbelė	100 g N1		Nereceptinis	LT/1/96/0391/008	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2012-02-28	Perregistruotas
1996-07-11	Registruotas