REZOLSTA

Medicinal product

(Invented) name

REZOLSTA

Active substance (s)

Darunaviras/Kobicistatas

Strength

600 mg/90 mg

Pharmaceutical form

disperguojamosios tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AR14, Darunavir and cobicistat

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2014-11-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Darunaviras	600 mg
Kobicistatas	90 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
122171	108282	1108282	buteliukas	N30		Receptinis	EU/1/14/967/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-11-19	Registruotas