Febuxostat Krka

Medicinal product

(Invented) name

Febuxostat Krka

Active substance (s)

Febuksostatas

Strength

80 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	80 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
101357	87460	1087460	lizdinė plokštelė	N14		Receptinis	EU/1/18/1347/001	Netiekiama	-	-	No	-	-
101358	87461	1087461	lizdinė plokštelė	N28		Receptinis	EU/1/18/1347/002	Netiekiama	-	-	No	-	-
101359	87462	1087462	lizdinė plokštelė	N56		Receptinis	EU/1/18/1347/003	Netiekiama	-	-	No	-	-
101360	87463	1087463	lizdinė plokštelė	N84		Receptinis	EU/1/18/1347/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-03-28	Registruotas