Difortan [Etofenamate Phagecon]

Medicinal product

(Invented) name

Difortan [Etofenamate Phagecon]

Active substance (s)

Etofenamatas

Strength

100 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)

M02AA06, Etofenamate

Marketing authorisation holder

US Pharmacia Sp. z o.o., Lenkija

Date of authorisation

2023-05-12

Date of renewal

Documents

5183 Difortan RPP 2024 04 22.docx

5183 Pakuotės lapelis 2024 04 22.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

EE/H/0419/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g gelio yra:	1 g
Etofenamatas	100 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
110992	97103	1097103	tūbelė	50 g N1		Nereceptinis	LT/1/23/5183/001	Netiekiama	-	-	No	-	-
110993	97104	1097104	tūbelė	100 g N1		Nereceptinis	LT/1/23/5183/002	Tiekiama	2025-04-09	-	No	-	-	Download

Stadijos

Data	Stadija
2023-05-12	Registruotas