Nizoral

Medicinal product

(Invented) name

Nizoral

Active substance (s)

Ketokonazolas

Strength

20 mg/g

Pharmaceutical form

šampūnas

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D01AC08, Ketoconazole

Marketing authorisation holder

STADA Arzneimittel AG, Vokietija

Date of authorisation

1995-10-04

Date of renewal

2007-11-30

Documents

0937 Nizoral sampunas RPP 2025 10 27.docx

0937 Pakuotės lapelis 2025 10 27.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g šampūno yra	1 g
Ketokonazolas	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
8445	13162	1013162	buteliukas	60 ml N1		Nereceptinis	LT/1/95/0937/002	Tiekiama	-	-	No	-	-	Download
105809	91909	1091909	buteliukas	100 ml N1		Nereceptinis	LT/1/95/0937/003	Tiekiama	-	-	No	-	-	Download
118977	105083	1105083	buteliukas	200 ml N1		Nereceptinis	LT/1/95/0937/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-11-30	Perregistruotas
1995-10-04	Registruotas