Ortofen

Medicinal product

(Invented) name

Ortofen

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

Limited Liability Company LMP, Latvija

Date of authorisation

2001-03-08

Date of renewal

2011-10-20

Documents

2662 Ortofen RPP 2025 09 02.docx

2662 Pakuotės lapelis 2025 09 02.docx

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
8522	13234	1013234	tūbelė	40 g N1		Nereceptinis	LT/1/01/2662/001	Netiekiama	-	-	No	-	-	Download
118604	104707	1104707	tūbelė	50 g N1		Nereceptinis	LT/1/01/2662/002	Netiekiama	-	-	No	-	-
118605	104708	1104708	tūbelė	100 g N1		Nereceptinis	LT/1/01/2662/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-10-20	Perregistruotas
2001-03-08	Registruotas