Ophenic [Oktenidinas/Fenoksietanolis FGK]

Medicinal product

(Invented) name

Ophenic [Oktenidinas/Fenoksietanolis FGK]

Active substance (s)

Oktenidinas/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

Schulke & Mayr GmbH, Vokietija

Date of authorisation

2015-09-30

Date of renewal

Documents

3802_1_2 Ophenic_RPP 180330.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/3849//001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Oktenidinas	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
54921	68947	1068947	buteliukas	50 ml su pompa N1		Nereceptinis	LT/1/15/3802/001	Netiekiama	-	-	No	-	-
63761	78204	1078204	buteliukas	250 ml su pompa N1		Nereceptinis	LT/1/15/3802/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-03	Išregistruotas
2015-09-30	Registruotas