OLYSIO

Medicinal product

(Invented) name

OLYSIO

Active substance (s)

Simepreviras

Strength

150 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AP05, Simeprevir

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2014-05-14

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsules	1 vnt.
Simepreviras	150 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
59169	73392	1073392	lizdinė plokštelė	N7		Receptinis	EU/1/14/924/001	Netiekiama	-	-	No	-	-
59170	73393	1073393	lizdinė plokštelė	N28		Receptinis	EU/1/14/924/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-03-07	Išregistruotas
2014-05-14	Registruotas