Xofluza

Medicinal product

(Invented) name

Xofluza

Active substance (s)

Baloksaviras marboksilas

Strength

40 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)

J05AX25, baloxavir marboxil

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2021-01-07

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

Film-coated tablet	1 vnt.
Baloksaviras marboksilas	40 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
105637	91737	1091737	lizdinė plokštelė	N2		Receptinis	EU/1/20/1500/002	Netiekiama	-	-	No	-	-
108531	94635	1094635	lizdinė plokštelė	N1		Receptinis	EU/1/20/1500/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-07	Registruotas