Harvoni

Medicinal product

(Invented) name

Harvoni

Active substance (s)

Ledipasviras/Sofosbuviras

Strength

90 mg/400 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)

J05AP51, Sofosbuvir and ledipasvir

Marketing authorisation holder

Gilead Sciences Ireland UC, Airija

Date of authorisation

2014-11-17

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.
Ledipasviras	90 mg
Sofosbuviras	400 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
60672	74960	1074960	buteliukas	N28		Receptinis	EU/1/14/958/001	Netiekiama	-	-	No	-	-
60673	74961	1074961	buteliukas	N84 (3x28)		Receptinis	EU/1/14/958/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-11-17	Registruotas