Prezista

Medicinal product

(Invented) name

Prezista

Active substance (s)

Darunaviras

Strength

100 mg/ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AE10, Darunavir

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2007-12-12

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

Oral suspension	1 ml
Darunaviras	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
54364	68356	1068356	buteliukas	200 ml N1 (+dozavimo pipetė)		Receptinis	EU/1/06/380/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-12-12	Registruotas