DicloFlex

Medicinal product

(Invented) name

DicloFlex

Active substance (s)

Diklofenakas

Strength

40 mg/g

Pharmaceutical form

odos purškalas (tirpalas)

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

MIKA Pharma GmbH, Vokietija

Date of authorisation

2006-09-11

Date of renewal

2008-03-06

Documents

0552_1_3 DicloFlex puskalas RPP keit.docx

0552_1_3 DicloFlex odos pursk RPP 151016.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 g tirpalo yra	1 g
Diklofenakas	40 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
18105	21828	1021828	buteliukas	10 ml (10 ml/7,5 g) N1		Nereceptinis	LT/1/06/0552/001	Netiekiama	-	-	No	-	-
18106	21829	1021829	buteliukas	15 ml (15 ml/12,5 g) N1		Nereceptinis	LT/1/06/0552/002	Netiekiama	-	-	No	-	-
18107	21830	1021830	buteliukas	30 ml (30 ml/25 g) N1		Nereceptinis	LT/1/06/0552/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-03-23	Išregistruotas
2008-03-06	Perregistruotas
2006-09-11	Registruotas