Nizoral

Medicinal product

(Invented) name

Nizoral

Active substance (s)

Ketokonazolas

Strength

20 mg/g

Pharmaceutical form

kremas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D01AC08, Ketoconazole

Marketing authorisation holder

UAB Johnson & Johnson, Lietuva

Date of authorisation

1995-10-04

Date of renewal

2007-11-30

Documents

0937_1 Pakuotės lapelis 210114.docx

0937_1 Nizoral 20mg_g kremas PCS PL 210114.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g kremo 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
9513	14156	1014156	tūbelė	15 g, N1		Receptinis	LT/1/95/0937/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-04-30	Išregistruotas
2007-11-30	Perregistruotas
1995-10-04	Registruotas