Olfen

Medicinal product

(Invented) name

Olfen

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

Teva B.V., Nyderlandai

Date of authorisation

2020-09-30

Date of renewal

2025-01-13

Documents

4613 Olfen gelis RPP 2025 10 10.docx

4613 Pakuotės lapelis 2025 10 10.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/5493/002/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
105072	91175	1091175	tūbelė	30 g N1		Nereceptinis	LT/1/20/4613/001	Netiekiama	-	-	No	-	-
105073	91176	1091176	tūbelė	50 g N1		Nereceptinis	LT/1/20/4613/002	Tiekiama	-	-	No	-	-	Download
105074	91177	1091177	tūbelė	60 g N1		Nereceptinis	LT/1/20/4613/003	Netiekiama	-	-	No	-	-
105075	91178	1091178	tūbelė	100 g N1		Nereceptinis	LT/1/20/4613/004	Tiekiama	-	-	No	-	-	Download
105076	91179	1091179	tūbelė	150 g N1		Nereceptinis	LT/1/20/4613/005	Netiekiama	-	-	No	-	-
105077	91180	1091180	tūbelė	180 g N1		Nereceptinis	LT/1/20/4613/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-13	Perregistruotas
2020-09-30	Registruotas