Ketoconazole Esteve [Ketoconazole HRA]

Medicinal product

(Invented) name

Ketoconazole Esteve [Ketoconazole HRA]

Active substance (s)

Ketokonazolas

Strength

200 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H02CA03, ketoconazole

Marketing authorisation holder

Esteve Pharmaceuticals S.A., Ispanija

Date of authorisation

2014-11-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Ketokonazolas	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
60808	75098	1075098	lizdinė plokštelė	N60		Receptinis	EU/1/14/965/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-11-19	Registruotas