Febuxostat Krka

Medicinal product

(Invented) name

Febuxostat Krka

Active substance (s)

Febuksostatas

Strength

120 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M04AA03, Febuxostat

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2019-03-28

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Febuksostatas	120 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
101361	87464	1087464	lizdinė plokštelė	N14		Receptinis	EU/1/18/1347/005	Netiekiama	-	-	No	-	-
101362	87465	1087465	lizdinė plokštelė	N28		Receptinis	EU/1/18/1347/006	Netiekiama	-	-	No	-	-
101363	87466	1087466	lizdinė plokštelė	N56		Receptinis	EU/1/18/1347/007	Netiekiama	-	-	No	-	-
101364	87467	1087467	lizdinė plokštelė	N84		Receptinis	EU/1/18/1347/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-03-28	Registruotas