Zepatier

Medicinal product

(Invented) name

Zepatier

Active substance (s)

Elbasviras/Grazopreviras

Strength

50 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)

J05AP54, Elbasvir and grazoprevir

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2016-07-22

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.
Elbasviras	50 mg
Grazopreviras	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
66268	80792	1080792	lizdinė plokštelė	N28		Receptinis	EU/1/16/1119/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-07-22	Registruotas