Mikanisal

Medicinal product

(Invented) name

Mikanisal

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

AS Grindeks, Latvija

Date of authorisation

2010-11-10

Date of renewal

2015-12-22

Documents

2213 Pakuotės lapelis 2024 10 16, VRA_19535.docx

2213 Mikanisal PL 2024 10 16, VRA_19535.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

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
30493	32954	1032954	buteliukas	60g N1		Nereceptinis	LT/1/10/2213/001	Tiekiama	-	-	No	-	-	Download
43740	57515	1057515	buteliukas	100 g N1		Nereceptinis	LT/1/10/2213/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-12-22	Perregistruotas
2010-11-10	Registruotas