CRESEMBA

Medicinal product

(Invented) name

CRESEMBA

Active substance (s)

Izavukonazolas

Strength

100 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J02AC05, Izavukonazolas

Marketing authorisation holder

Basilea Pharmaceutica Deutschland GmbH, Vokietija

Date of authorisation

2015-10-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsule	1 vnt.
Izavukonazolas	100 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
64068	78515	1078515	lizdinė plokštelė	N14		Receptinis	EU/1/15/1036/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-10-15	Registruotas