Vosevi

Medicinal product

(Invented) name

Vosevi

Active substance (s)

Sofosbuviras/Velpatasviras/Voksilapreviras

Strength

400 mg/100 mg/100 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)

J05AP56, Sofosbuvir, velpatasvir and voxilaprevir

Marketing authorisation holder

Gilead Sciences Ireland UC, Airija

Date of authorisation

2017-07-26

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.
Sofosbuviras	400 mg
Velpatasviras	100 mg
Voksilapreviras	100 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
97563	83657	1083657	buteliukas	N28		Receptinis	EU/1/17/1223/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-07-26	Registruotas