Epclusa

Medicinal product

(Invented) name

Epclusa

Active substance (s)

Sofosbuviras/Velpatasviras

Strength

400 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)

J05AP55, Sofosbuvir and velpatasvir

Marketing authorisation holder

Gilead Sciences Ireland UC, Airija

Date of authorisation

2016-07-06

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

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
66260	80783	1080783	buteliukas	N28		Receptinis	EU/1/16/1116/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-07-06	Registruotas