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 Limedika, Lietuva

Date of authorisation

2017-03-15

Date of renewal

Documents

0479_Nizoral šampunas_PZPL_2019-05-03.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Viename grame 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
67918	82478	1082478	buteliukas	120 ml N1		Nereceptinis	LT/L/17/0479/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-15	Registruotas