Ditel

Medicinal product

(Invented) name

Ditel

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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2023-04-18

Date of renewal

Documents

5171 Ditel PCS PL 2024 10 16.docx

5171 Pakuotės lapelis 2024 10 16.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/7329/001/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
110846	96957	1096957	tūbelė	30 g N1		Nereceptinis	LT/1/23/5171/001	Netiekiama	-	-	No	-	-
110847	96958	1096958	tūbelė	50 g N1		Nereceptinis	LT/1/23/5171/002	Tiekiama	-	-	No	-	-	Download
110848	96959	1096959	tūbelė	60 g N1		Nereceptinis	LT/1/23/5171/003	Netiekiama	-	-	No	-	-
110849	96960	1096960	tūbelė	100 g N1		Nereceptinis	LT/1/23/5171/004	Tiekiama	-	-	No	-	-	Download
110850	96961	1096961	tūbelė	120 g N1		Nereceptinis	LT/1/23/5171/005	Netiekiama	-	-	No	-	-
110851	96962	1096962	tūbelė	150 g N1		Nereceptinis	LT/1/23/5171/006	Netiekiama	-	-	No	-	-
110852	96963	1096963	tūbelė	180 g N1		Nereceptinis	LT/1/23/5171/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-18	Registruotas