Duoseptic

Medicinal product

(Invented) name

Duoseptic

Active substance (s)

Oktenidino dihidrochloridas/Fenoksietanolis

Strength

1 mg/20 mg/ml

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

Bausch Health Ireland Limited, Airija

Date of authorisation

2017-01-03

Date of renewal

2023-07-26

Documents

4024_pakuotes lapelis_2023-07-26.docx

4024_Duoseptic_perr2023-07-26.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PL/H/0401/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Oktenidino dihidrochloridas	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
62561	76972	1076972	buteliukas	50 ml su dozavimo pompa N1		Nereceptinis	LT/1/17/4024/001	Tiekiama	-	-	No	-	-	Download
67340	81890	1081890	buteliukas	250 ml su dozavimo pompa N1		Nereceptinis	LT/1/17/4024/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-26	Perregistruotas
2017-01-03	Registruotas