Onytec

Medicinal product

(Invented) name

Onytec

Active substance (s)

Ciklopiroksas

Strength

80 mg/g

Pharmaceutical form

vaistinis nagų lakas

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D01AE14, Ciclopirox

Marketing authorisation holder

Polichem SA, Liuksemburgas

Date of authorisation

2012-05-09

Date of renewal

2018-07-12

Documents

2928 Pakuotės lapelis 2022 11 17.docx

2928 Onytec PCS PL 2022 11 17.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/2952/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g lako yra	1 g
Ciklopiroksas	80 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
42554	56321	1056321	buteliukas	3,3 ml N1		Nereceptinis	LT/1/12/2928/001	Tiekiama	-	-	No	-	-	Download
42555	56322	1056322	buteliukas	6,6 ml N1		Nereceptinis	LT/1/12/2928/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-12	Perregistruotas
2012-05-09	Registruotas