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

UAB Lex ano, Lietuva

Date of authorisation

2021-07-14

Date of renewal

Documents

1564_Nizoral_2021-07-14.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
107026	93129	1093129	buteliukas	100 ml N1		Nereceptinis	LT/L/21/1564/001	Netiekiama	-	-	No	-	-
107027	93130	1093130	buteliukas	120 ml N1		Nereceptinis	LT/L/21/1564/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-07-14	Registruotas