Harvoni

Medicinal product

(Invented) name

Harvoni

Active substance (s)

Ledipasviras/Sofosbuviras

Strength

45 mg/200 mg

Pharmaceutical form

dengtos granulės paketėlyje

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

Coated granules in sachet	1 vnt.
Ledipasviras	45 mg
Sofosbuviras	200 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
104744	90845	1090845	paketėlis	N28		Receptinis	EU/1/14/958/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-11-17	Registruotas