MYKOSEPTIN

Medicinal product

(Invented) name

MYKOSEPTIN

Active substance (s)

Undecileno rūgštis/Cinko undecilenatas

Strength

50 mg/200 mg/g

Pharmaceutical form

tepalas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D01AE04, Undecylenic acid

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

1999-06-04

Date of renewal

2010-08-04

Documents

2130_1 Mykoseptin tepalas PZ keit.doc

2130_1 Mykoseptin tepalas RPP 151030.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g tepalo yra	1 g
Undecileno rūgštis	50 mg
Cinko undecilenatas	200 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
4912	10234	1010234	tūbelė	30 g N1		Receptinis	LT/1/99/2130/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2018-04-05	Išregistruotas
2010-08-04	Perregistruotas
1999-06-04	Registruotas