Prezista

Medicinal product

(Invented) name

Prezista

Active substance (s)

Darunaviras

Strength

800 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

2013-01-14

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	800 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
55517	69566	1069566	buteliukas	N30		Receptinis	EU/1/06/380/007	Netiekiama	-	-	No	-	-
56688	70791	1070791	buteliukas	N90 (3 x 30), daugiadozis		Receptinis	EU/1/06/380/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-01-14	Registruotas