Xofluza

Medicinal product

(Invented) name

Xofluza

Active substance (s)

Baloksaviras marboksilas

Strength

40 mg

Pharmaceutical form

granulės paketėlyje

Route (s) of administration

vartoti į burną ir ryklę

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

1 paketėlyje yra	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
118169	104277	1104277	paketėlis	N1		Receptinis	EU/1/20/1500/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-07	Registruotas