Diflazon

Medicinal product

(Invented) name

Diflazon

Active substance (s)

Flukonazolas

Strength

200 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)

J02AC01, Fluconazole

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

1998-12-23

Date of renewal

2008-12-18

Documents

1377 Pakuotės lapelis kaps 2024 12 20.docx

1377 Diflazon kaps PCS PL 2024 12 20.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Flukonazolas	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
10472	15048	1015048	lizdinė plokštelė	N7		Receptinis	LT/1/98/1377/004	Netiekiama	-	-	No	-	-
10473	15049	1015049	lizdinė plokštelė	N20		Receptinis	LT/1/98/1377/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-12-18	Perregistruotas
1998-12-23	Registruotas