oktiseptas

Medicinal product

(Invented) name

oktiseptas

Active substance (s)

Oktenidino dihidrochloridas/Fenoksietanolis

Strength

1 mg/20 mg/ml

Pharmaceutical form

odos tirpalas

Route (s) of administration

vartoti ant odos, vartoti ant pažeistos vietos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D08AJ57, Octenidine, combinations

Marketing authorisation holder

UAB Sanovus, Lietuva

Date of authorisation

2014-10-16

Date of renewal

2019-05-14

Documents

3640 oktiseptas RPP 2022 06 27.docx

3640 Pakuotės lapelis 2022 06 27.docx

Octenid-phenox_Apiterapija_AR.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml odos 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
57073	71185	1071185	buteliukas	50 ml su purškalo pompa N1		Nereceptinis	LT/1/14/3640/001	Tiekiama	-	-	No	-	-	Download
60432	74709	1074709	buteliukas	250 ml su purškalo pompa N1		Nereceptinis	LT/1/14/3640/002	Tiekiama	-	-	No	-	-
60433	74710	1074710	buteliukas	250 ml N1		Nereceptinis	LT/1/14/3640/003	Netiekiama	-	-	No	-	-
60434	74711	1074711	buteliukas	500 ml N1		Nereceptinis	LT/1/14/3640/004	Netiekiama	-	-	No	-	-
60435	74712	1074712	buteliukas	1000 ml N1		Nereceptinis	LT/1/14/3640/005	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-05-14	Perregistruotas
2014-10-16	Registruotas