Prezista

Medicinal product

(Invented) name

Prezista

Active substance (s)

Darunaviras

Strength

75 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)

J05AE10, Darunavir

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2009-06-23

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.
Darunaviras	75 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
50368	64252	1064252	buteliukas	N480		Receptinis	EU/1/06/380/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-06-23	Registruotas