Xofluza

Medicinal product

(Invented) name

Xofluza

Active substance (s)

Baloksaviras marboksilas

Strength

2 mg/ml

Pharmaceutical form

granulės geriamajai suspensijai

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

Granules for oral sispension	1 ml
Baloksaviras marboksilas	2 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
110195	96304	1096304	buteliukas	matavimo taurelė, buteliuko adapteris, 2 geriamieji švirkštai (3 ml ir 10 ml) N1		Receptinis	EU/1/20/1500/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-07	Registruotas