Linoseptic

Medicinal product

(Invented) name

Linoseptic

Active substance (s)

Oktenidino hidrochloridas/Fenoksietanolis

Strength

1 mg/20 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)

D08AJ57, Octenidine, combinations

Marketing authorisation holder

Dr. August Wolff GmbH & Co. KG Arzneimittel, Vokietija

Date of authorisation

2014-10-27

Date of renewal

2019-07-25

Documents

3646_2_4 Pakuotės lapelis 210115.docx

3646_2_4 Linoseptic odos purskalas PL 210115.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/3491/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g tirpalo yra	1 g
Oktenidino hidrochloridas	1 mg
Fenoksietanolis	20 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
49173	63041	1063041	buteliukas	30 ml N1		Nereceptinis	LT/1/14/3646/002	Tiekiama	-	-	No	-	-
60444	74722	1074722	buteliukas	100 ml N1		Nereceptinis	LT/1/14/3646/003	Netiekiama	-	-	No	-	-
104214	90318	1090318	buteliukas	50 ml N1		Nereceptinis	LT/1/14/3646/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-08-29	Išregistruotas
2019-07-25	Perregistruotas
2014-10-27	Registruotas