Darunavir Krka

Medicinal product

(Invented) name

Darunavir Krka

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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2018-01-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

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
98861	84965	1084965	buteliukas	N30		Receptinis	EU/1/17/1249/009	Netiekiama	-	-	No	-	-
98862	84966	1084966	buteliukas	N90 (3x30)		Receptinis	EU/1/17/1249/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-01-26	Registruotas