Fluconazole Actavis

Medicinal product

(Invented) name

Fluconazole Actavis

Active substance (s)

Flukonazolas

Strength

150 mg

Pharmaceutical form

kietoji kapsulė

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2017-01-03

Date of renewal

2021-04-19

Documents

4027 Fluconazole Actavis_perr2021-04-19.doc

4027 pakuotes lapelis_2021-04-19.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0303/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Flukonazolas	150 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
60972	75281	1075281	lizdinė plokštelė	N1		Receptinis	LT/1/17/4027/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-06-30	Išregistruotas
2021-04-19	Perregistruotas
2017-01-03	Registruotas