Octezy

Medicinal product

(Invented) name

Octezy

Active substance (s)

Oktenidino dihidrochloridas/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

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2024-11-21

Date of renewal

Documents

5632_pakuotes lapelis_2024-11-21.docx

5632_Octezy-corr.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

HU/H/0842/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g tirpalo yra:	1 g
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
115701	101804	1101804	buteliukas	30 ml N1		Nereceptinis	LT/1/14/5632/001	Nepradėtas tiekti	-	-	No	-	-
115702	101805	1101805	buteliukas	50 ml N1		Nereceptinis	LT/1/14/5632/002	Tiekiama	-	-	No	-	-
115703	101806	1101806	buteliukas	100 ml N1		Nereceptinis	LT/1/14/5632/003	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-21	Registruotas